Stockwinners Market Radar for November 09, 2018 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
NKTR | Hot Stocks18:22 EDT Nektar presents new results from PIVOT-02 Phase 1/2 Study - Nektar Therapeutics announced a presentation of new clinical and preclinical data for its I-O pipeline at the 2018 Society for Immunotherapy of Cancer Annual Meeting. New clinical study results from the PIVOT-02 Phase 1/2 Study were shared in an oral presentation titled, "Immune monitoring after NKTR-214 plus nivolumab (PIVOT-02) in previously untreated patients with metastatic Stage IV melanoma" (Abstract #O4) by Adi Diab, MD, Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center during the Cytokines Reinvented Session on Friday, November 9th. Additional preclinical data presented at the annual meeting showed that NKTR-214 may drive, sustain and expand anti-tumor response when combined with therapies with complementary mechanisms of action including NKTR-262, poly (ADP-ribose) polymerase inhibitors, radiation therapy and other agents. When combined with these treatments, NKTR-214 showed the potential to lead to tumor clearance and tumor specific immunologic memory. "The data presented at this year's SITC Annual Meeting showcase our pipeline of novel investigational I-O agents that target key components of the immune cycle in order to restore immune surveillance and harness the body's immune system to fight cancer," said Jonathan Zalevsky, Ph.D., Senior Vice President and Chief Scientific Officer at Nektar Therapeutics. "Clinical data presented for NKTR-214 show that NKTR-214 plus nivolumab give deep and durable responses in first-line IO-naive Stage IV melanoma patients, including a high rate of complete responses. For our TLR agonist candidate, NKTR-262, we presented data demonstrating alteration of the tumor micro-environment, including activating the innate and adaptive arms of the immune system along with encouraging anti-tumor activity."
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AXP... | Hot Stocks17:58 EDT Third Point adds American Express and Merck, exits Facebook and Wynn - Third Point disclosed in an SEC filing its holdings as of September 30, 2018. Third Point's seven new buys during the quarter included, by size of position, American Express (AXP), Merck (MRK), Shire (SHPG), Iqvia (IQV), and Diamondback Energy (FANG). The fund exited thirteen positions during the quarter, including by size of previous position NXP Semiconductors (NXPI), Facebook Class A (FB), Vulcan Materials (VMC), Wynn Resorts (WYNN), and Electronic Arts (EA). Third Point increased its stake in ten holdings, including by size of previous position Campbell Soup (CPB), Microsoft (MSFT), United Technologies (UTX), Constellation Brands Class A (STZ), and Adobe (ADBE). The fund reduced its stake in six holdings, including by size of previous position Netflix (NFLX), Lennar Class A (LEN), S&P Global (SPGI), PayPal (PYPL), and Salesforce.com (CRM). Third Point's top holdings as of September 30, 2018, in order of size, were Baxter (BAX), United Technologies, PayPal, Alibaba (BABA), and Campbell Soup.
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ALKS AMRX | Hot Stocks17:45 EDT PTAB institutes inter partes review of Alkermes patent for Vivitrol - As previously disclosed on April 20, Amneal Pharmaceuticals (AMRX) filed a petition with the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office seeking an inter partes review of Alkermes' (ALKS) U.S. Patent Number 7,919,499, which is an Orange Book-listed patent for Vivitrol, challenging the validity of the patent. On November 7, the PTAB issued an order instituting an IPR of claims 1-13 of the '499 patent, Alkermes disclosed tonight in a regulatory filing. A decision on the matter is expected by November 7, 2019.
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ESGR | Hot Stocks17:35 EDT Enstar Group, Maiden Holdings agree to loss portfolio transfer - Enstar Group announced that it has signed an agreement with Maiden Holdings and Maiden Reinsurance Ltd., a subsidiary of Maiden. Pursuant to the agreement, an Enstar subsidiary would enter into a retrocession agreement to effect a loss portfolio transfer in which the Enstar subsidiary would assume loss reserves of approximately $2.675B associated with Maiden Re's quota share reinsurance contracts with AmTrust Financial Services and its subsidiaries. The retrocession will apply to losses arising and/or claims made on or prior to June 30, 2018, and loss reserves assumed will be subject to adjustment for paid losses since such date. The transaction is subject to regulatory approvals and other closing conditions. This represents Enstar's second agreed transaction with Maiden, following the entrance into a definitive agreement in August 2018 to acquire Maiden Reinsurance North America, Inc. That transaction remains subject to regulatory approvals and closing conditions and is expected to be completed in the fourth quarter of 2018.
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ACM | Hot Stocks17:33 EDT Aecom awarded $117.34M Army contract - Aecom was awarded an $117.34M firm-fixed-price contract for major rehabilitation, demolition, temporary facilities, surveying, dewatering and protecting lock chamber, blasting, removing and replacing horizontal concrete at Illinois River Basin, LaGrange Lock and Dam. Bids were solicited via the internet with one bid received. Work will be performed in Versailles, Illinois, with an estimated completion date of July 16, 2021. FY19 operations and maintenance, Army funds in the amount of $24.7M were obligated at the time of the award. U.S. Army Contracting Command is the contracting activity.
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SAIC | Hot Stocks17:26 EDT SAIC awarded $900.31M Defense Logistics contract - SAIC has been awarded a $900.31M firm-fixed-price, requirements contract for supply and supply chain management of certain tires, supporting the Global Tire Program integrator contract. This was a competitive acquisition with two responses received. This is a five-year base contract with two two-year option periods, plus four two-month option periods. Locations of performance are Texas and other areas located outside the continental U.S., with a March 8, 2024, performance completion date. Using customers are Army, Navy, Air Force, Marine Corps, Coast Guard and foreign military sales. Type of appropriation is FY19 through 2024 defense working capital funds; and foreign military sales funds. The contracting activity is the Defense Logistics Agency Land and Maritime.
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ALGT | Hot Stocks17:23 EDT Allegiant Travel reports October total systems traffic up 5.2% - Reports total systems passengers up 5.9%. Reports available seat miles, or ASM, up 4.6%. Reports total system load factor up 0.4pts at 80.5%. Reports total system departures up 4.6%.
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DAIO | Hot Stocks17:15 EDT DH Partners reports 5.9% passive stake in Data I/O
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VBTX | Hot Stocks17:13 EDT BlackRock reports 14.6% passive stake in Veritex
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BLK VBTX | Hot Stocks17:13 EDT BlackRock reports 14.6% passive stake in Veritex
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BLK TTGT | Hot Stocks17:12 EDT BlackRock reports 11.7% passive stake in TechTarget
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CHEF | Hot Stocks17:12 EDT BlackRock reports 12.4% passive stake in Chefs' Warehouse
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ANH | Hot Stocks17:12 EDT Anworth Mortgage names Joseph McAdams as new board chairman - Anworth Mortgage Asset Corporation announced that Lloyd McAdams will step down from his role as Chairman of the Board, effective November 15, 2018. Mr. McAdams, 73, will continue as a member of Anworth's Board of Directors. Mr. McAdams will be succeeded as Chairman of the Board by Joseph E. McAdams. Joseph E. McAdams, 49, currently serves as a member of Anworth's Board of Directors and, since September 30, 2018, serves as the Company's Chief Executive Officer.
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AXTA | Hot Stocks17:09 EDT Axalta to initiate global price increase for transportation coatings - Axalta Coating Systems will initiate a global price increase for its transportation coatings effective on December 1, or as contracts with customers permit. The increase will apply to light vehicle and commercial vehicle coatings.
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PRTH | Hot Stocks17:07 EDT Parthus Technologies says stock will remain listed on Nasdaq Global Market - Priority Technology Holdings announced that it has been informed by Nasdaq that shares of the company's common stock will continue to remain listed on the Nasdaq Global Market. Additionally, its warrants and units have been granted extensions to remain listed through February 27, 2019. The company had previously received notice of non-compliance with Nasdaq Listing Rules 5404a3, 5410d and 5225b1A because its shares of common stock, warrants and units, respectively, were held by fewer than the required 400 round lot holders. However, the company was able to successfully demonstrate compliance with respect to its shares of common stock subsequent to receipt of the Non-Compliance Notice. While it did not satisfy the Minimum Public Holders Rules as it relates to its outstanding warrants and units, the Nasdaq Hearings Panel opted to grant the company's request for an extension of time in order to permit the exploration of alternatives to address the lack of sufficient round lot holders for the warrants and units.
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HLTH | Hot Stocks17:02 EDT Nobilis Health to delay filing Form 10-Q - Nobilis Health announced it has filed a Form 12b-25 Notification of Late Filing with the SEC relating to its 10-Q for the period ended September 30, 2018. In the filing, the Company stated that additional time is required for the Company and the auditor to complete their review of the Company's financial statements in order to finalize the 10-Q. The Company is re-evaluating the Net Realizable Value on its Accounts Receivable and intends to make a significant adjustment to the carrying value of accounts receivable, primarily on out of network claims greater than 365 days old. The final adjustment is subject to the completion of the Company and the auditor's review. "We are deeply disappointed by the slow pace of our collection efforts that have resulted in this impact to our receivables, which will have a significant negative impact on our financial results for 2018. Over the last several months we have completely overhauled the process and leadership of our revenue cycle and continue to improve our billing and collection processes and procedures. We continue to work towards the collection of receivables," said Kenny Klein, CFO. "This 12b-25 filing gives the company an additional 5 days to file its 10-Q and still be deemed to have been a timely filer. The company is working diligently with our auditors to complete the review of our financial statements."
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GTX | Hot Stocks16:54 EDT BlackRock reports 11.7% passive stake in Garrett Motion
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VIA VIAB | Hot Stocks16:42 EDT Viacom extends CFO Davis' employment to November 30, 2019 - According to a regulatory filing, Viacom entered into a letter agreement with executive VP and CFO Wade C. Davis on November 8, 2018, effective as of November 1, 2018, to extend Davis's term of employment to November 30, 2019. The other terms and conditions of Mr. Davis's employment agreement, dated as of November 27, 2014, remain the same, except that Davis is now eligible to receive annual grants of equity compensation with a target value of $2,750,000, increased from $2,250,000.
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JACK | Hot Stocks16:40 EDT Blue Harbour Group reports 6.8% stake in Jack in the Box
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CLNC | Hot Stocks16:39 EDT Colony Credit Real Estate announces resignation of CFO Sujan Patel - Effective November 9, 2018, Sujan S. Patel resigned from all positions at Colony Credit Real Estate, including Mr. Patel's position as Chief Financial Officer and Treasurer of the Company, to pursue other opportunities. The board announced that it has unanimously approved the appointment of Neale W. Redington as Chief Financial Officer and Treasurer of the Company, and Frank V. Saracino as Chief Accounting Officer of the Company. Mr. Redington was previously the Company's Chief Accounting Officer.
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AXNX | Hot Stocks16:33 EDT Longitude Capital Partners III reports 11% stake in Axonics
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CHEF | Hot Stocks16:30 EDT Chefs' Warehouse CEO sells 200,000 common shares - In a regulatory filing, Chefs' Warehouse president and CEO Christopher Pappas disclosed the sale of 200,000 common shares of the company at a price of $36.95 per share.
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ISCA | Hot Stocks16:30 EDT International Speedway trading resumes
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MRK | Hot Stocks16:23 EDT FDA approves Merck's Keytruda in HCC patients - Merck announced that the FDA has approved Keytruda, Merck's anti-PD-1 therapy, for the treatment of patients with hepatocellular carcinoma, or HCC, who have been previously treated with sorafenib. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The approval was based on data from KEYNOTE-224, a single-arm, open-label, multicenter trial evaluating Keytruda in 104 patients with HCC who had disease progression on or after sorafenib or were intolerant to sorafenib. Patients received Keytruda 200 mg every three weeks until unacceptable toxicity or confirmed disease progression. Patients without disease progression were treated for up to 24 months. Assessment of tumor status was performed every nine weeks. The major efficacy outcome measures were objective response rate and duration of response, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ, as assessed by blinded independent central review.
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RMBL | Hot Stocks16:23 EDT Steven R. Brewster reports 7.54% passive stake in RumbleON
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DBD | Hot Stocks16:22 EDT Gabelli raises Diebold stake to 11.16% from 11.03% - In a regulatory filing, Gabelli disclosed an 11.16% stake in Diebold Nixdorf and said that GAMCO is currently evaluating three "highly-qualified" candidates to serve shareholders on Diebold's board of directors. GAMCO intends on moving forward with the nomination of at least two of these candidates in accordance with the procedures outlined in the company's Code of Regulations.
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FE | Hot Stocks16:22 EDT FirstEnergy declares increased dividend of 38c per share for March 2019 - FirstEnergy announced that its Board of Directors has approved a dividend policy that reflects the company's confidence in its growth initiatives. The new policy includes a targeted payout ratio of 55%-65% of the company's operating earnings. As a first step, the Board declared a dividend of 38c per common share payable on March 1, 2019, to shareholders of record as of February 7, 2019. This represents an increase of 6% compared to quarterly payments of 36c per common share paid by the company since 2014.
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OCCI | Hot Stocks16:20 EDT Thomas J. Herzfeld Advisors reports 10.45% passive stake in OFS Credit
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APAM | Hot Stocks16:19 EDT Artisan Partners reports AUM $106.6B as of October 31st vs. $116.6B last month
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CVTI | Hot Stocks16:18 EDT Covenant Transportation CEO Parker reinstates 10b5-1 trading plan - Covenant Transportation announced that David Parker, CTG's Chairman and CEO, and his wife, Jacqueline Parker, have reinstated a written sales plan in accordance with Rule 10b5-1 of the Securities and Exchange Act of 1934, as amended, and CTG's policies regarding stock transactions for the sale of up to 234,347 shares of CTG Class A common stock. Sales under the 10b5-1 Trading Plan are subject to certain market conditions. Sales may commence on November 15, 2018 and would be completed by November 15, 2019.
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RMNI ORCL | Hot Stocks16:18 EDT Rimini Street says appellate court to consider appeal of injunction - Rimini Street (RMNI) issued the following statement regarding the recent court ruling on the motion to stay the injunction: "Once again, Oracle's (ORCL) apparent fear of Rimini Street's strong value proposition and compelling 'Business-Driven Roadmap' alternative that has been successfully implemented by a growing list of more than 2,600 clients since 2005, including more than 150 Fortune 500 and Global 100 clients, appears to be fueling its misleading and increasingly desperate marketing campaign. The U.S. Ninth Circuit Court of Appeals found that Rimini Street 'provided third-party support for Oracle's enterprise software, in lawful competition with Oracle's direct maintenance services.' In 2016, following the Oracle v. Rimini Street trial, the U.S. District Court issued an overly broad and vague injunction against Rimini Street. The injunction purported to address former support processes that are no longer in use, and that have not been used since July 2014 at the latest. Rimini Street immediately appealed the injunction to the Court of Appeals, citing numerous legal flaws. In January 2018, the Court of Appeals vacated that flawed injunction and remanded the matter back to the District Court for reconsideration. On August 15, 2018, the District Court imposed substantially the same flawed injunction that the Court of Appeals had previously vacated, and Rimini Street immediately moved to again appeal the injunction. On November 5, 2018, the Court of Appeals affirmed the briefing schedule for the appeal, but denied Rimini Street's motion for a stay of the injunction pending resolution of the appeal. The Court of Appeals provided no reason for its denial of the stay motion, and the order does not address the merits of Rimini Street's appeal. Rimini Street looks forward to once again having the legally-flawed injunction vacated on appeal." Rimini added, "Rimini Street plans to hold Oracle accountable for any illegal or anticompetitive activity, as it is doing presently with its claims against Oracle filed in a separate lawsuit brought by Rimini Street against Oracle in 2014, Rimini Street v. Oracle, which is pending in the District Court and expected to go to trial in 2021 or later."
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DTE | Hot Stocks16:16 EDT DTE Energy raises quarterly dividend 7% to 94.5c per share - The DTE Energy board of directors declared a 94.5c per share dividend on its common stock payable Jan. 15, 2019, to shareholders of record at the close of business Dec. 17, 2018. This is a 6.25c per share - or seven percent - increase from the previous quarterly dividend of 88.25c per share and reflects the Board's confidence in the company's growth plans. The new annualized dividend per share is $3.78, up from $3.53.
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AXNX | Hot Stocks16:11 EDT Cormorant Asset Management reports 4.8% passive stake in Axonics
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WBT | Hot Stocks16:09 EDT Welbilt to delay filing Form 10-Q - Welbilt has experienced unexpected delays in the filing of its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2018 within the prescribed time period due to the circumstances described below. The delays could not be eliminated without unreasonable effort or expense. As disclosed in its Current Report on Form 8-K filed with the SEC on November 5, 2018, the Company's previously issued consolidated financial statements as of and for the year ended December 31, 2016 should no longer be relied upon because of prior period errors. The errors primarily relate to the computation of income taxes associated with intercompany distributions by foreign entities and intercompany obligations in accordance with underlying agreements. The Company intends to file an amended Annual Report on Form 10-K for the year ended December 31, 2017 to restate its consolidated financial statements as of and for the year ended December 31, 2016, and to revise its consolidated financial statements as of and for the years ended December 31, 2015 and 2017, in each case to reflect the correction of these tax errors. Additionally, the Company has reassessed the effectiveness of the Company's internal control over financial reporting and disclosure controls and procedures in light of the errors described above. The Company has determined that a material weakness relating to income taxes existed as of December 31, 2017 and through September 30, 2018, and therefore the Company's internal control over financial reporting and disclosure controls and procedures for income taxes were ineffective. Accordingly, in the Form 10-K/A, the Company will restate management's report on internal control over financial reporting and its evaluation of disclosure controls and procedures and will receive an adverse opinion on the internal control over financial reporting as of December 31, 2017 from PricewaterhouseCoopers LLP, the Company's independent registered public accounting firm. The Company is working to prepare the Form 10-K/A and complete the restatement and revisions described above as soon as practicable and, therefore, is not able to complete its interim unaudited financial statements and file the Form 10-Q on or prior to the due date without unreasonable effort or expense. The Company currently expects that it will be able to conclude the remaining work in time to file the Form 10-Q within the five day extension period provided by Rule 12b-25.
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LL | Hot Stocks16:07 EDT Morgan Stanley reports 5.3% passive stake in Lumber Liquidators
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WLDN | Hot Stocks16:06 EDT Willdan Group completes acquisition of Lime Energy - Willdan Group announced the completion of its previously announced acquisition of Lime Energy Co., a national provider of innovative energy solutions for utilities and their commercial customers. Under the terms of the agreement, Willdan acquired all of the outstanding shares of capital stock of Lime Energy for $120M in cash, exclusive of customary holdbacks and adjustments. Willdan expects the acquisition of Lime Energy to further expand and diversify Willdan's customer base and to better position Willdan to take advantage of anticipated upcoming contract and budget expansions in California and the Northeastern United States.
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ISCA | Hot Stocks16:05 EDT NASCAR offers to acquire International Speedway for $42 per share - International Speedway Corporation announced that its board of directors has received a non-binding offer from NASCAR to acquire all of the outstanding shares of Class A common stock and Class B common stock of the company, other than the shares held by the controlling shareholders of ISC, for a cash purchase price of $42.00 per share. The intention is to combine ISC and NASCAR as one privately-held group of companies with the France family as primary owners. "In a highly competitive sports and entertainment landscape, a more unified strategic approach is important to our future growth. We believe the industry requires structural changes to best position the sport for long term success and this offer represents a positive step forward in that direction," said Jim France, Chairman of ISC and Chairman and Chief Executive Officer, NASCAR. NASCAR's proposal letter indicates that the outcome of this prospective offer will not impact the France family's long-term commitment to the sport, nor its interest in maintaining its current ownership in ISC, as the France family is not interested in selling its shares of ISC at this time, the company noted. The ISC board has formed a special committee of independent directors to act on behalf of the company to consider this proposal. In the interim, NASCAR and ISC will continue to operate as separate and independent entities. "The company cautions shareholders and others considering trading in its securities that the Board just received the non-binding proposal letter from NASCAR and no decisions have been made with respect to the company's response to the proposal. There can be no assurance that any definitive offer will be made, that any agreement will be executed or that this or any other transaction will be approved or consummated," the company said.
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ATHN | Hot Stocks16:05 EDT Athenahealth reports Q3 bookings $46.6M vs. $65.7M last year - Q3 gross margin prior to the impact of the new revenue recognition standard was 54.0% vs. 54.4% last year.
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ISCA | Hot Stocks16:02 EDT NASCAR offers to acquire International Speedway for $42 per share
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ISCA | Hot Stocks16:00 EDT International Speedway trading halted, news pending
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TSRO CLVS | Hot Stocks15:50 EDT Tesaro sinks after disclosing data while Clovis rises - Shares of Tesaro (TSRO) have sunk after the company presented initial data from the Phase 1 AMBER trial of TSR-022 in combination with TSR-042 in patients who have progressed following anti-PD-1 therapy treatment, in an oral session during the 2018 Annual Meeting of the Society for Immunotherapy of Cancer, or SITC, Conference. In late day trading, Tesaro shares are down $6.46, or 20.9%, to $24.46. Meanwhile, shares of Clovis Oncology (CLVS) are up about 1% to $15.80.
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TSRO | Hot Stocks15:47 EDT TESARO trading resumes
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TSRO | Hot Stocks15:46 EDT Tesaro reports initial data from AMBER trial of TSR-022, TSR-042 combo - TESARO presented initial data from the Phase 1 AMBER trial of TSR-022 in combination with TSR-042 in patients who have progressed following anti-PD-1 therapy treatment, in an oral session during the 2018 Annual Meeting of the Society for Immunotherapy of Cancer, or SITC, Conference in Washington, D.C. Data presented at SITC included safety and efficacy data from the combination dose-escalation and two expansion cohorts: NSCLC patients that had progressed following anti-PD-1 treatment and melanoma patients that had progressed following anti-PD-1 treatment. At the time of data cutoff, 39 patients with NSCLC who had progressed following anti-PD-1 treatment had received treatment with the TSR-022 and TSR-042 combination, including 14 patients at the 100 milligram dose and 25 patients at the 300 milligram dose of TSR-022. Among the 11 evaluable patients treated with the 100 milligram dose of TSR-022, 1 had a confirmed partial response by immune related RECIST criteria and 3 had stable disease. Among the 20 evaluable patients treated with the 300 milligram dose of TSR-022, 3 had confirmed partial responses and 8 had stable disease. "The initial AMBER data featured at this year's SITC conference are the first clinical data to be presented for an anti-TIM-3 antibody in combination with an anti-PD-1 antibody and demonstrated that the combination of TSR-022 and TSR-042 is active and generally well tolerated in NSCLC and melanoma patients who have progressed following anti-PD-1 treatment. Additionally, updated results from the GARNET trial demonstrated robust clinical activity of TSR-042 in previously treated, anti-PD-1 naive patients with recurrent or advanced NSCLC, the vast majority of which had TPS less than50%. We look forward to presenting additional data from these studies in 2019," said COO Mary Lynne Hedley. Additionally, Phase 1 GARNET data of TSR-042 in patients with previously treated recurrent/advanced non-small cell lung cancer and Phase 1 monotherapy dose-escalation data for TSR-033 in a broad range of solid tumors were also highlighted in poster presentations.
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TSRO | Hot Stocks15:42 EDT TESARO trading halted, volatility trading pause
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TEAM | Hot Stocks15:37 EDT Capital Research Global Investors reports 10.6% passive stake in Atlassian
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CRCM | Hot Stocks15:37 EDT Capital Research Global Investors reports 10.5% passive stake in Care.com
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CPB | Hot Stocks15:36 EDT Campbell Soup recommends shareholders vote to support current board - Campbell Soup issued a letter from its interim President and CEO, Keith McLoughlin, to its shareholders in connection with its 2018 Annual Meeting of Shareholders, scheduled for Nov. 29, 2018. In the letter, McLoughlin reiterates Campbell's openness and willingness to consider board refreshment. Campbell said it strongly recommends that shareholders vote to support the current Campbell board of directors with a vote on the GOLD proxy card. "Two years ago, we retained the well-respected executive search firm Russell Reynolds Associates to undertake an "evergreen" director search process so that at any given time we would have a list of qualified potential candidates to serve on the Campbell Board," the letter reads. "We currently have a list of about a dozen candidates who we are considering for any upcoming vacancies, including vacancies due to three planned retirements occurring over the next three years. Our focus when selecting new directors will continue to be choosing individuals with proven track records of operating and turning around businesses, particularly in our industry. You should know that we have had proactive conversations with Third Point over the last few weeks-including yesterday and today regarding our ongoing director refreshment process-and we have asked Third Point for their input. We proposed adding two individuals to our Board after our annual meeting, including Kurt Schmidt and Sarah Hofstetter from the Third Point slate. From the beginning, we have told Third Point that our director selection criteria are simple: We can only consider adding individuals who are truly open to all strategic alternatives and who are free from employment conflicts that would impair that openness or limit the ability to maintain Board confidentiality, which would exclude Third Point employees. Third Point rejected this proposal. Instead, they have decided to continue this wasteful and distracting proxy fight. Nonetheless, we believe it is important for all of our shareholders to know that we are offering to add two new independent directors, Mr. Schmidt and Ms. Hofstetter, from the Third Point slate, as we continue to refresh our Board. We have solicited and will continue to welcome shareholder input into our director selection process-either from Third Point or from any other shareholder. The Campbell Board will continue to be open to any change that will drive long-term shareholder value, and we welcome input from all of our shareholders with respect to that process."
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OPHT | Hot Stocks15:30 EDT Versant Side Fund reports 12.2% passive stake in Ophthotech
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MDB | Hot Stocks15:23 EDT Capital World Investors reports 14.9% passive stake in MongoDB
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TBPH MYL | Hot Stocks15:16 EDT Theravance Biopharma, Mylan confirm FDA approval for Yupelri - Theravance Biopharma (TBPH) and Mylan (MYL) announced that the U.S. FDA has approved the New Drug Application for Yupelri inhalation solution for the maintenance treatment of patients with chronic obstructive pulmonary disease. Yupelri, a long-acting muscarinic antagonist, is the first and only once-daily, nebulized bronchodilator approved for the treatment of COPD in the US. The companies expect YUPELRI to be available to COPD patients in the US before the end of the year.
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PFE | Hot Stocks15:14 EDT Pfizer announces availability of data from Phase 2 PALLET study - Pfizer announced that results from the Phase 2 PALLET study of Ibrance will be presented at the 41st Annual San Antonio Breast Cancer Symposium, or SABCS. The abstract is now accessible on the SABCS website ahead of the oral presentation on December 6, Pfizer noted. The abstract for the study states that 307 patients were recruited and that 103 were randomized to letrozole alone and 204 to letrozole + palbociclib. "Clinical response was not significantly different between letrozole vs letrozole + palbociclib groups, nor was the small proportion of patients with pathological CR," the abstract states. The conclusion of the abstract reads: "Adding palbociclib to letrozole markedly enhanced the suppression of malignant cell proliferation as assessed by Ki67 but did not substantially increase the clinical response of primary ER+ breast cancer over a 14-week period. Concurrent reductions in cell death may have reduced the speed of tumor shrinkage." Reference Link
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BBY... | Hot Stocks14:56 EDT Best Buy slides as Amazon reportedly expands Apple product selection - Shares of Best Buy (BBY) are slipping in afternoon trading following a report that Amazon (AMZN) has signed a deal to sell more Apple (AAPL) products. WHAT'S NEW: CNET reported earlier today that Amazon has inked a deal with Apple to expand the selection of the iPhone maker's products on Amazon worldwide. Amazon will soon begin selling more Apple devices directly and have access to the company's latest products, including new iPads, iPhones, Apple Watch Series 4, as well as Beats headphones, the report says. PRICE ACTION: In afternoon trading, Best Buy shares are down 6.6% to $68.45.
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AXP | Hot Stocks14:47 EDT Third Point discloses new position in American Express in quarterly letter - In its Third Quarter 2018 Investor Letter, Third Point reported that the Third Point Offshore fund was down 0.1% in the quarter and is up 0.6% year-to-date, stating "Underperformance forces us to take a hard look at how our process let us down and, in this letter, we will try to share with you what we think has gone wrong this year and what could still go right." In terms of a new position, Third Point revealed it has taken a stake in American Express, as the firm thinks new CEO Stephen Squeri's focus on topline growth and underappreciated structural opportunities will "lead to more sustainable double-digit EPS growth going forward." Third Point noted in the letter, viewed by The Fly, that it sees AmEx shares "trading above $135 over the next 18 months for a total return of 30% upside."
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PCG | Hot Stocks14:21 EDT PG&E says 25,000 customers currently without power due to Camp Fire - Pacific Gas and Electric Company reports that it is supporting first responders and local agencies and has mobilized its Emergency Operations Center in San Francisco, as well as multiple local operations centers, to support wildfire emergency response to the Camp Fire in Butte and Plumas counties. "PG&E's first priority is the safety of customers, employees, contractors and the communities it serves," the company stated. As of 9:00 a.m., the fire has burned about 70,000 acres. Approximately 25,000 PG&E customers are currently without power due to the impacts of the Camp Fire. At the request of first responders, PG&E turned off power to some customers as an emergency precaution to support safety and firefighting efforts. Others lost power due to fire-damaged equipment. As a safety precaution, PG&E also turned off gas service to about 12,000 customers in and around the City of Paradise. PG&E has provided an initial electric incident report to the Safety and Enforcement Division of the California Public Utilities Commission. The information provided in this report is preliminary and PG&E will fully cooperate with any investigations. There has been no determination on the causes of the Camp Fire, PG&E stated.
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HES BP | Hot Stocks14:17 EDT Hess says Aspy probe did not encounter commercial quantities of hydrocarbons - Hess Corporation (HES) announced that drilling of the Aspy exploration well offshore Nova Scotia reached total depth of 7,400 meters. The prospect did not encounter commercial quantities of hydrocarbons and Hess' share of the well cost through September 30, 2018 will be expensed in the third quarter and reflected in the company's quarterly report on Form 10-Q. BP Canada (BP) as operator and Hess each hold a 50% participating interest.
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HUD | Hot Stocks13:36 EDT Brown Advisory reports 5.69% passive stake in Hudson
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JNPR | Hot Stocks13:34 EDT Juniper drops $1.07, to $29.60 after issuing outlook at investor day
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JNPR | Hot Stocks13:27 EDT Juniper drops nearly 4% to $29.54 as company hosts Investor Day
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TBPH | Hot Stocks13:23 EDT Theravance Biopharma granted FDA approval for Yupelri - Theravance Biopharma's Yupelri has been approved by the FDA for the maintenance treatment of patients with chronic obstructive pulmonary disease, according to the agency's website. Reference Link
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CYAD | Hot Stocks13:15 EDT Celyad trading resumes
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BHGE | Hot Stocks13:03 EDT Baker Hughes reports U.S. rig count up 14 to 1,081 rigs - Baker Hughes reports that the U.S. rig count is up 14 rigs from last week to 1,081, with oil rigs up 12 to 886 and gas rigs up 2 to 195. The U.S. Rig Count is up 174 rigs from last year's count of 907, with oil rigs up 148 and gas rigs up 26. The U.S. Offshore Rig Count is up 3 rigs to 21 and up 3 rigs year-over-year. The Canada Rig Count is down 2 rigs from last week to 196, with oil rigs down 4 to 117 and gas rigs up 2 to 79. The Canada Rig Count is down 7 rigs from last year's count of 203, with oil rigs up 9 and gas rigs down 16.
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CYAD | Hot Stocks12:50 EDT Celyad presents update on CYAD-01 solid tumor clinical program - Celyad announced updated clinical results for the CYAD-01 program in solid tumors as well as translational research data presented at the Society for Immunotherapy of Cancer, or SITC, 33rd Annual Meeting. In the THINK Phase 1 dose-escalation trial, 14 patients with relapsed/refractory disease were enrolled in the trial, evaluating CYAD-01 without preconditioning chemotherapy at three different dose levels of one cycle of three administrations with two-week intervals. Overall four patients experienced confirmed disease stabilization, three mCRC patients and one patient with ovarian cancer, according to RECIST 1.1 criteria. As a monotherapy treatment, CYAD-01 was well tolerated. The peak level of peripheral CYAD-01 cells detected seem to correlate with the dose level and clinical response. In the SHRINK Phase 1 open-label, dose-escalation trial, patients will receive six cycles of FOLFOX chemotherapy every two weeks and three administrations of CYAD-01 every two weeks 48 hours after the end of chemotherapy at cycles two, three and four. To date, enrollment of dose level one has been completed with three metastatic treatment-naive patients. All patients have undergone resection without delays in surgery. Initial activity results assessed by pathological response criteria showed all three patients achieved an objective clinical response, including one patient with a pCR and two patients with pPR. Concurrent treatment of CYAD-01 with FOLFOX chemotherapy appears to be well tolerated, with no occurrence of serious AEs nor increase of treatment-related AEs rate. In addition, the expansion of peripheral CYAD-01 cells with a concurrent administration of FOLFOX chemotherapy is similar to the one observed with the standalone CYAD-01. Full data from the SHRINK Phase 1 trial are expected in mid-2019. Frederic Lehmann, VP of Clinical Development & Medical Affairs at Celyad, commented, "Solid tumors remain the greatest current challenge for any T cell therapy. One of the major hurdles is the lack of suitable targets, and in our perspective, NKG2D ligands that are targeted by CYAD-01 represent an attractive family of targets on solid tumors that may be exploited by our clinical candidates. I am encouraged that to date CYAD-01 is well tolerated as a monotherapy for the treatment of mCRC, while preliminary observations of clinical activity in the form of disease stabilization imply that there is potential for the approach. Furthermore, the initial findings of clinical activity reported from the initial dose level of CYAD-01 when administered concurrently with standard-of-care chemotherapy in the SHRINK trial are encouraging and provide support for this view."
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TCFC | Hot Stocks12:42 EDT Community Financial announces CLO, COO plan to retire in 2019 - Community Financial, the holding company for Community Bank of the Chesapeake, announced that the Chief Lending Officer and Chief Operating Officer intend to retire in 2019. James Di Misa, the company's and the bank's Chief Operating Officer, will retire from the company and the bank effective March 31, 2019. Di Misa will continue to serve in an advisory capacity through December 31, 2019 to ensure a smooth transition. The Board of Directors has promoted Christy Lombardi to Executive Vice President and Chief Operating Officer of the company and the bank effective upon Di Misa's retirement. Lombardi currently serves as the bank's and the company's Executive Vice President and Chief Administrative Officer. Gregory Cockerham, the company's and the bank's Chief Lending Officer, will retire from the company and the bank effective December 31, 2019. Effective on January 1, 2019, Patrick Pierce, currently Senior Vice President, Senior Lender, will become Executive Vice President, Maryland Market Banking Officer.
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CYAD | Hot Stocks12:40 EDT Celyad trading halted, news pending
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ARWR | Hot Stocks12:10 EDT Arrowhead presents clinical data from Phase 1 study of ARO-AAT - Arrowhead Pharmaceuticals announced clinical data from a Phase 1 study of ARO-AAT, the company's second generation subcutaneously administered RNA interference therapeutic being developed as a treatment for a rare genetic liver disease associated with alpha-1 antitrypsin deficiency, will be presented in a late-breaking poster at The Liver Meeting, the Annual Meeting of the American Association for the Study of Liver Disease, being held in San Francisco. In the AROAAT1001 study, 45 normal healthy volunteers received a single dose of ARO-AAT, three monthly doses of ARO-AAT or placebo. Key data presented include the following: ARO-AAT at single- and multiple-doses produced robust and consistent reductions in serum AAT levels. Single-doses of 200 and 300 mg resulted in greater than 91% serum AAT reduction, with 3 of 4 subjects having concentrations below the level of quantitation. In 200 and 300 mg single-dose cohorts, an average serum AAT reduction of greater than 90% was sustained for 6 weeks. In the multiple-dose cohorts of 200 and 300 mg, for subjects receiving all 3 doses, an average of greater than 90% reduction in serum AAT was sustained for longer than 14 weeks. The maximum NADIR reduction is 94%. Monthly serum AAT follow up is ongoing with 9 of 10 subjects at BLQ in the multiple-dose cohorts, including 100% of subjects from the 300 mg cohort. Duration of response indicates that quarterly or less frequent dosing appears feasible. ARO-AAT has been well tolerated at all doses tested given three times every 28 days. The most common adverse events were upper respiratory tract infection and headache.
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ARWR JNJ | Hot Stocks12:07 EDT Arrowhead presents preliminary clinical data from Phase 1/2 study of ARO-HBV - Arrowhead Pharmaceuticals (ARWR) announced preliminary clinical data from a Phase 1/2 study of ARO-HBV, a third-generation subcutaneously administered RNA interference therapeutic candidate being developed as a potential treatment for patients with chronic hepatitis B virus infection. Arrowhead recently entered into a license agreement with Janssen Pharmaceuticals, part of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), to develop and commercialize ARO-HBV. Initial results from normal healthy volunteers who received a single dose of ARO-HBV or placebo and chronic hepatitis B patients who received three monthly doses of ARO-HBV in combination with entecavir or tenofovir with greater than six weeks of available hepatitis B surface antigen data include the following: ARO-HBV administered subcutaneously appears to be well-tolerated at single or multiple monthly doses up to 400 mg, mild injection site reactions were observed with approximately 12% of subcutaneous injections; Strong HBsAg responses were observed in all HBV patients, Mean NADIR -1.9 Log10, Range -1.3 to -3.8 Log10; HBsAg reductions were similar in hepatitis B e-antigen positive and HBeAg negative patients, Mean HBsAg NADIR in HBeAg positive -2.1 Log10, Mean HBsAg NADIR in HBeAg negative -1.8 Log10; HBsAg reductions were similar for NUC naive patients and NUC experienced patients, Mean HBsAg reduction on day 57 for cohort 8 -1.7 Log10,Mean HBsAg reduction on day 57 for cohort 9 -1.9 Log10. This study highlighted an improvement over results with Arrowhead's first-generation compound ARC-520, which targeted only HBV transcripts derived from cccDNA. HBsAg responses observed with ARO-HBV are consistent with the ability of ARO-HBV to silence HBV mRNA from cccDNA and host-integrated viral DNA, a major source of HBsAg in certain patient populations. Responses were also observed in all other virologic parameters.
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CNC | Hot Stocks12:06 EDT Centene reports Health Net of California earns 4 of 5 stars from CMS - Health Net of California, a subsidiary of Centene Corporation, has earned four of five stars from the Centers for Medicare and Medicaid Services in their annual Star Ratings report, the company announced. CMS elevated the company's rating for the 2019 plan year from 3.5 to 4.0 stars for the Health Net Medicare Advantage plan for California, Centene stated. Steven Sell, president of Health Net of California, said, "This rating reflects that focus and the positive impact of our patient engagement initiatives that enhance the quality of care and customer service our members receive."
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BMY | Hot Stocks12:03 EDT Bristol-Myers granted orphan status for lung cancer treatment - The FDA, according to a post on its website, granted Bristol-Myers Squibb orphan status for Ipilimumab, the company's treatment of small cell lung cancer. Reference Link
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GD | Hot Stocks11:31 EDT General Dynamics awarded federal health care quality measurement contract - General Dynamics announced that the Centers for Medicare & Medicaid Services' Center for Clinical Standards & Quality has awarded the Measure and Instrument Development and Support contract to General Dynamics Information Technology. The multiple-award, indefinite delivery, indefinite quantity contract will allow GDIT to bid on individual task orders related to federal health care quality management. The contract holds an estimated ceiling value of $1.6B and includes a base period of five years, with an additional five-year option period.
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AIZ | Hot Stocks11:31 EDT Assurant raises quarterly common stock dividend 7% to 60c per share - Assurant announced that its Board of Directors approved a quarterly dividend increase of 4c to 60c per share of common stock. The dividend will be payable on Dec. 17, 2018 to stockholders of record as of the close of business on Nov. 26, 2018.
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CEMI | Hot Stocks11:16 EDT Chembio confirms FDA authorized emergency use of Ebola diagnostic test - Chembio Diagnostics announced the receipt of U.S. Food and Drug Administration Emergency Use Authorization for its DPP Ebola Antigen System for use with human capillary "fingerstick" whole blood, EDTA venous whole blood, and EDTA plasma. The DPP Ebola Antigen System includes the DPP Ebola Assay and DPP Micro Reader. The DPP Ebola Antigen System is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Ebola virus and/or diagnosis of EVD. John Sperzel, Chembio's CEO, said, "Our patented DPP technology continues to serve as a robust platform for the rapid detection of infectious diseases, and we hope to receive support and funding as we pursue additional regulatory approvals for our rapid Ebola test."
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CEMI | Hot Stocks11:03 EDT FDA authorizes emergency use of Chembio Diagnostics' Ebola fingerstick test - The U.S. Food and Drug Administration announced that an emergency use authorization, or EUA, has been issued for a rapid, single-use test for the detection of Ebola virus. This is the second Ebola rapid antigen fingerstick test available under EUA, but the first that uses a portable battery-operated reader, which can help provide clear diagnostic results outside of laboratories and in areas where patients are likely to be treated. The test, called the DPP Ebola Antigen System, is used with blood specimens, including capillary "fingerstick" whole blood, from individuals with signs and symptoms of Ebola virus disease in addition to other risk factors, such as living in an area with large numbers of EVD cases and/or having contact with other individuals exhibiting signs and symptoms of EVD. With the issuance of the EUA for the DPP Ebola Antigen System to Chembio Diagnostic Systems Inc., the FDA has now issued EUAs for nine nucleic acid tests and two rapid diagnostic tests for Ebola virus detection in human specimens, the FDA noted.
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CEMI | Hot Stocks10:38 EDT FDA allows emergency use of Chembio ebola test - The FDA stated in an emailed statement to Bloomberg: "With the issuance of the EUA for the DPP Ebola Antigen System to Chembio Diagnostic Systems Inc., the FDA has now issued EUAs for nine nucleic acid tests and two rapid diagnostic tests for Ebola virus detection in human specimens"
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TRP | Hot Stocks10:31 EDT TransCanada launches binding open season for Marketlink - TransCanada Corporation launched an open season to solicit binding commitments from interested parties for transportation services of crude oil from Cushing, Oklahoma to markets on the U.S. Gulf Coast on incremental capacity on Marketlink.
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REV TLRY | Hot Stocks10:24 EDT Revlon jumps after reporting results, detailing new streamlining plan - Shares of Revlon (REV) jumped in morning trading after the global beauty company reported results for its fiscal third quarter and announced a restructuring plan. In addition to the core Revlon brand, the company also owns Elizabeth Arden and Almay. THIRD QUARTER RESULTS: Though its earnings per share including items was a loss of (21c), Revlon reported adjusted EPS of 14c for the quarter, which compares to one analyst estimate of (40c) and (38c) last year. Revenue for the quarter was $655.4M, compared to one analyst estimate of $639.6M and $666.5M last year. Revlon segment net sales in Q3 were down 2% vs. last year to $249.5M, Elizabeth Arden segment net sales gained 16.5% to $122.1M and fragrances segment net sales declined 8.7% to 145.4M. "We are very pleased with our third quarter results and believe that they are reflective of the strength of our business strategy and efforts to stabilize our business operations," President and Chief Executive Officer Debra Perelman said in a statement. She added that Revlon is "seeing strong growth in our strategic focus areas as we continue to work to build momentum across our businesses." STREAMLINING PLAN: In conjunction with its quarterly results, Revlon announced a new 2018 Optimization Program to streamline its operations, reporting structures and business processes with the goal of improving productivity, profitability, cash flows and liquidity. The company expects to recognize $30M-$40M in total pre-tax restructuring and related charges, consisting of employee-related costs, such as severance, pension and other termination costs, as well as other expenses. Of the charges, Revlon expects to record restructuring charges of $8M-$10M in the fourth quarter. The company sees $125M-$150M of annualized cost reductions by the end of 2019. WHAT'S NOTABLE: On October 23, MoxReports tweeted: "i am long $REV on the idea of shorts that go sharply UP in tough markets. $REV float is now 96% gone and short exceeds remaining float. that is why it is already UP today and will spike much higher." MoxReports previously said in a report that the "infinity squeeze potential appears even more extreme at Revlon than it did at Tilray (TLRY)" due to recent changes in ownership and short interest. PRICE ACTION: In morning trading, shares of Revlon are up over 19% to $26.00.
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ABT | Hot Stocks10:16 EDT NY AG announces settlement with Abbott over infant-feeding surveys - New York Attorney General Barbara Underwood announced a settlement resolving an investigation into Abbott Laboratories, maker of Similac infant formula, over misleading marketing surveys the company sent to new parents about their infant-feeding habits. The settlement requires Abbott to accurately disclose the purpose for which survey information is sought and prohibits Abbott from falsely representing that their surveys are being conducted for scientific study. The settlement also requires Abbott to pay $50,000 in costs.
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CPB | Hot Stocks10:02 EDT Third Point amends proxy to nominate 5 directors to Campbell Soup board - Third Point, a holder of approximately 7% of the outstanding common shares of Campbell Soup Company, sent a letter to the company's Board of Directors notifying its Chairman that it has amended proxy materials to nominate five independent director nominees for election at Campbell's Annual Meeting of Shareholders on November 29, 2018. The Short Slate includes Sarah Hofstetter, Munib Islam, Bozoma Saint John, Kurt Schmidt and William Toler. "The letter explains that after weeks of meetings with our fellow shareholders, Third Point has done something that Campbell and its Board refuse to do: embrace and respect the input of non-insiders. We now understand that the Short Slate is exactly what is needed to set Campbell on a sustainable path to renewed competitiveness and growth."
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BRS | Hot Stocks10:00 EDT Bristow Group falls -16.2% - Bristow Group is down -16.2%, or -$1.63 to $8.41.
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ADNT | Hot Stocks10:00 EDT Adient falls -21.0% - Adient is down -21.0%, or -$6.06 to $22.77.
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YELP | Hot Stocks10:00 EDT Yelp falls -28.3% - Yelp is down -28.3%, or -$12.30 to $31.20.
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WOW | Hot Stocks10:00 EDT WideOpenWest rises 11.0% - WideOpenWest is up 11.0%, or $1.14 to $11.52.
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HTZ | Hot Stocks10:00 EDT Hertz rises 14.7% - Hertz is up 14.7%, or $2.39 to $18.68.
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REV | Hot Stocks10:00 EDT Revlon rises 15.6% - Revlon is up 15.6%, or $3.39 to $25.19.
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BPI | Hot Stocks09:47 EDT Bridgepoint Education falls -10.3% - Bridgepoint Education is down -10.3%, or -$1.03 to $8.93.
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ADNT | Hot Stocks09:47 EDT Adient falls -15.8% - Adient is down -15.8%, or -$4.55 to $24.28.
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YELP | Hot Stocks09:47 EDT Yelp falls -31.1% - Yelp is down -31.1%, or -$13.55 to $29.95.
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UGAZ | Hot Stocks09:47 EDT VelocityShares 3x Long Natural Gas ETN rises 9.9% - VelocityShares 3x Long Natural Gas ETN is up 9.9%, or $10.61 to $118.25.
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HTZ | Hot Stocks09:47 EDT Hertz rises 17.2% - Hertz is up 17.2%, or $2.81 to $19.10.
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REV | Hot Stocks09:47 EDT Revlon rises 22.0% - Revlon is up 22.0%, or $4.80 to $26.60.
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WELL | Hot Stocks09:18 EDT Welltower & Hines acquire Manhattan site for seniors housing community - Welltower and the New York office of international real estate firm Hines have closed on the acquisition of a development site at 2330 Broadway at 85th Street on the Upper West Side of Manhattan. Existing commercial structures on the site will be demolished to make way for construction of a state of the art 140,000-sq.ft., 17-story senior living and memory care community. The site on the northeast corner of 85th Street and Broadway is the second Manhattan senior living development site for the joint venture partnership of Hines, Welltower, and a passive institutional investor.
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WRB | Hot Stocks09:15 EDT W. R. Berkley declares special cash dividend of 50c per share - W. R. Berkley Corporation announced today that its Board of Directors has declared a special cash dividend on its common stock of 50c per share to be paid on December 12, 2018 to stockholders of record at the close of business on November 28, 2018. Together with the two 50c per share special dividends that were paid on June 18, 2018 and October 3, 2018, this brings special dividends during 2018 to $1.50 per share.
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MDP | Hot Stocks09:12 EDT Meredith to sell FORTUNE media brand for $150M cash to Fortune Media Group - Meredith announced an agreement to sell the FORTUNE media brand for $150M cash to Fortune Media Group Holdings Limited, wholly owned by Chatchaval Jiaravanon. The transaction is subject to regulatory approval and is expected to close in 2018. Jiaravanon will own FORTUNE as a personal private investment independent of C.P. Group's family businesses. He intends to increase investment in FORTUNE's digital capabilities, geographic expansion, and editorial talent as part of a strategy to become the premium business content provider worldwide.As part of the transaction, Meredith will provide short-term business continuity services and has entered a multi-year agreement with Mr. Jiaravanon to provide services such as corporate sales, consumer marketing, subscription fulfillment, paper purchasing and printing. Meredith acquired FORTUNE as part of its purchase of Time Inc., which closed on January 31, 2018. Shortly thereafter, Meredith announced it was selling Time Inc.'s news and sports brands - TIME, Sports Illustrated, FORTUNE and MONEY - to focus on brands serving its core audience of American women. Meredith closed on its sale of TIME to Marc and Lynne Benioff for $190 million on October 31, 2018. Meredith plans to use transaction proceeds to pay down debt. Meredith expects to reduce debt by $1 billion in fiscal 2019. Meredith is targeting a net debt-to-EBITDA ratio of 2x to 1 or better by the end of fiscal 2020. This includes generating $1 billion of EBITDA and having net debt below $2 billion by the end of fiscal 2020.
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NNA | Hot Stocks09:11 EDT Navios Acquisition stockholders approve reverse stock split - Navios Acquisition announced that the previously disclosed one-for-fifteen reverse split of its common stock was approved by the company's stockholders at a special meeting. The reverse stock split will be effected immediately before any trading commences prior to market open on November 14. The common stock will begin trading on November 14 on a split-adjusted basis on the New York Stock Exchange, under the same ticker symbol.
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EDRY | Hot Stocks09:10 EDT EuroDry to acquire M/V Star of Nippon drybulk carrier - EuroDry announced that it signed a memorandum of agreement to purchase the M/V Star of Nippon, a panamax size drybulk carrier of 75,845 dwt built in 2004 in Japan. The vessel is expected to be delivered to the company by the end of November 2018. The Company expects to finance the acquisition with funds at hand and debt which is in the process of arranging.
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KTOS | Hot Stocks09:08 EDT Kratos Defense receives $10M in new contract awards - Kratos Defense announced that it has recently received approximately $10M in new contract awards for Air Borne Electronic Warfare and Communications Systems. Due to customer related and other considerations, no additional information will be provided related to these recent contract awards.
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EIGI | Hot Stocks09:07 EDT Endurance appoints Tom Aurelio as Chief Human Resources Officer - Endurance appointed Tom Aurelio as Chief Human Resources Officer. Aurelio was most recently executive VP of human resources for Criteo, a publicly traded global marketing automation firm headquartered in Paris.
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SLS | Hot Stocks09:06 EDT Sellas Life Sciences announces data from nelipepimut-S +/- trastuzumab study - Sellas Life Science announced data from a preplanned secondary efficacy analysis across human leukocyte antigen, or HLA, allele subgroups from the prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical trial of the combination of nelipepimut-S +/- trastuzumab targeting HER2 low-expressing breast cancer patient cohorts. The data are being presented at the Society for Immunotherapy of Cancer, or SITC. The data presented confirm the therapeutic potential of NPS for patients with early-stage TNBC in the adjuvant setting across HLA types A-02, -03, -24 and -26 which cover approximately 80-85% of the North American/European populations and 86-90% of Asian/Pacific basin populations. In the subgroup of triple negative breast cancer, or TNBC, patients with the HLA-A24+ allele type, which is highly prevalent in the Asian population, treated with the combination of NPS and trastuzumab, the p-value is 0.003 with a 90.6% relative reduction in risk of relapse or death at 24 months and a hazard ratio of 0.08 in favor of the active arm. The data presented confirm the therapeutic potential of NPS for patients with early-stage TNBC in the adjuvant setting across HLA types A-02, -03, -24 and -26 which cover approximately 80-85% of the North American/European populations and 86-90% of Asian/Pacific basin populations. In the subgroup of triple negative breast cancer patients with the HLA-A24+ allele type, which is highly prevalent in the Asian population, treated with the combination of NPS and trastuzumab, the p-value is 0.003 with a 90.6% relative reduction in risk of relapse or death at 24 months and a hazard ratio of 0.08 in favor of the active arm.
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HMHC | Hot Stocks09:06 EDT Houghton Mifflin's Science Dimensions approved by California Board of Education - Houghton Mifflin announced that the California State Board of Education has approved California HMH Science Dimensions 2020, giving schools the opportunity to purchase and implement the curriculum in K-8 classrooms statewide. California HMH Science Dimensions was built and customized to meet the rigors of the state's Next Generation Science Standards.
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TNC | Hot Stocks09:04 EDT Tennant raises quarterly dividend by 5% to 22c per share - Tennant authorized a 5% increase in the company's quarterly cash dividend to 22c per share. The increased dividend is payable December 14, to shareholders of record at the close of business on November 30.
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JWN | Hot Stocks09:04 EDT Nordstrom mall of San Juan store reopens after Hurricane Maria - Nordstrom reopened its store to customers at the Mall of San Juan in Puerto Rico today. The store which originally opened in March 2015 had been closed since fall 2017 as a result of severe damage from Hurricane Maria. Nordstrom hired 130 employees in sales and support positions for the reopening, including 40 employees who were rehired or transferred back from the states.
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KCAP | Hot Stocks09:03 EDT LibreMax Capital to acquire Trimaran Advisors from KCAP Financial - LibreMax Capital announced that an affiliate has entered into a definitive agreement to acquire Trimaran Advisors and certain affiliated companies from KCAP Financial. Trimaran currently manages six CLOs with approximately $3B of assets under management. Following the close of the transaction, Trimaran's chief investment officer and head of its CLO platform, Dominick Mazzitelli, will continue to lead the business, supported by the existing management team. The transaction is subject to customary closing conditions and is expected to close by year end. Schulte Roth & Zabel LLP served as legal counsel for LibreMax on the transaction.
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BA | Hot Stocks09:02 EDT Boeing, Safran joint venture to begin operations - Boeing and Safran have received regulatory approvals for a joint venture so they can begin designing, building and servicing aircraft Auxiliary Power Units -onboard engines that are primarily used to start the main engines and power aircraft systems while on the ground and, if necessary, in flight. The companies also named Etienne Boisseau as Chief Executive Officer of the joint venture. The agreement establishes a partnership between two of the world's leading aerospace companies to work together on APU products and expanded service capabilities to benefit customers and industry. Both companies have a 50% stake in the joint venture. The initial team will perform design work in San Diego, Calif. The name of the joint venture as well as the location of the future headquarters and production and service facilities will be announced at a later date.
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FNSR... | Hot Stocks09:00 EDT Fly Intel: Pre-market Movers - HIGHER: Finisar (FNSR), up 20% after II-VI (IIVI) announced a definitive merger agreement to acquire the company in a cash and stock transaction with an equity value of approximately $3.2B, or $26 per share. II-VI shares are down 12% in pre-market trading following the deal announcement... StoneCo (STNE), up 2% after Berkshire Hathaway (BRK.A) disclosed a 11.3% passive stake in the company. UP AFTER EARNINGS: Disney (DIS), up 1%... Hertz (HTZ), up 16%... ForeScout (FSCT), up 9%... Dropbox (DBX), up 10%. DOWN AFTER EARNINGS: Yelp (YELP), down 31%... Natera (NTRA), down 15%... Activision Blizzard (ATVI), down 13%... Trade Desk (TTD), down 12%... CenturyLink (CTL), down 11%.
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ICAD | Hot Stocks08:57 EDT iCAD announces retirement of CEO, Ken Ferry - iCAD announced that Ken Ferry has retired from his position as Chief Executive Officer and stepped down as a Director of the Company, effective immediately. Michael Klein, Chairman of iCAD's Board, will serve as Executive Chairman and Interim CEO. "I am excited to serve in an executive capacity and lead the Company during this important and transformational period of growth," said Mr. Klein. "I believe that iCAD's unique AI technology has the potential to transform both cancer detection and the assessment of at-risk patients. I look forward to working with the executive management team as we execute a strategy to grow our existing business while accelerating our development as a broader spectrum AI Imaging company. Upon receipt of FDA clearance for our new artificial intelligence product, designed for digital breast tomosynthesis, we are well-positioned to optimize the unique opportunity that exists in both US and international markets. We are fervently focused on unlocking the significant inherent value that exists in iCAD's core technology, market presence and huge repository of CAD interpreted images." "On behalf of the entire Board, I would like to thank Ken for his contributions to iCAD throughout his 12 years as CEO. We wish him well in his future endeavors," continued Mr. Klein.
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ECOR | Hot Stocks08:47 EDT ElectroCore announces NICE MIB on gammaCore for cluster headaches - ElectroCore announced that the National Institute for Health and Care Excellence, or NICE, has published a Medtech innovation briefing, or MIB, on their non-invasive vagus nerve stimulator, or nVNS, gammaCore, for use in the treatment of cluster headache in adults. The report collates the most recent published evidence, and surmises that gammaCore is beneficial for people suffering with cluster headache. Clinical specialists propose that gammaCore has the potential to be a treatment option for people who haven't responded to, or can't tolerate currently available treatments. The opinion of three leading clinical experts and the advocacy group, Migraine Trust, were consulted in the development of the MIB. The report showed that the use of gammaCore alongside standard of care may be more effective than standard of care only in the treatment of cluster headaches. It also states that gammaCore does not need to be surgically implanted and does not require clinical monitoring.
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STN | Hot Stocks08:46 EDT Stantec announces automatic share repurchase plan, renewal of NCIB - Stantec announced that it has received approval from the Toronto Stock Exchange respecting the renewal of its Normal Course Issuer Bid, or NCIB. Pursuant to the NCIB documentation filed with the TSX, Stantec may purchase up to 2,273,879 common shares, representing approximately 2% of Stantec's 113,693,990 issued and outstanding common shares as of October 31, 2018. The purchases may commence on November 14, 2018 and will terminate no later than November 13, 2019. Except for block purchases permitted under the rules and policies of the TSX, the number of shares to be purchased per day will not exceed 46,458 or approximately 25% of the average daily trading volume for the six full calendar months ending October 31, 2018, which is 185,834 shares. Stantec will make the purchases on the open market through the facilities of the TSX or any alternative Canadian trading system, and the prices that Stantec will pay for any common shares will be the market price of such shares at the time of acquisition. All shares purchased by Stantec will be cancelled. The renewal of the NCIB follows on the conclusion of Stantec's previous NCIB that expires November 13, 2018. From November 14, 2017 to November 8, 2018, Stantec purchased 592,153 common shares at a weighted average price of $32.39 per share. Stantec also announced today that, in connection with its intention to implement the NCIB, Stantec has entered into an automatic share purchase plan, or ASPP, with a designated broker to allow for the purchase of its common shares under the NCIB, once effective, at times when Stantec normally would not be active in the market due to applicable regulatory restrictions or internal trading black-out periods. Before the commencement of any particular internal trading black-out period, Stantec may, but is not required to, instruct its designated broker to make purchases of Stantec's common shares under the NCIB during the ensuing black-out period in accordance with the terms of the ASPP. Such purchases will be determined by the broker in its sole discretion based on parameters established by Stantec prior to commencement of the applicable black-out period in accordance with the terms of the ASPP and applicable TSX rules. Outside of these black-out periods, common shares will be purchasable by Stantec at its discretion under its NCIB, once effective.
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SGMO | Hot Stocks08:46 EDT Sangamo says SMC recommends hemophilia A study continue with higher dose - Sangamo Therapeutics reported last night that in October, the independent Safety Monitoring Committee, or SMC, of the Phase 1/2 Alta Study evaluating SB-525 for hemophilia A reviewed accumulated safety and efficacy data from six patients enrolled in three dose cohorts. As of that review, SB-525 exhibited dose-dependent efficacy on serum factor levels and was generally well-tolerated with no treatment-related serious adverse events and no use of tapering courses of oral steroids. The SMC recommended that the study continue with escalation to an additional dose. Sangamo plans to present safety and efficacy data from the Alta Study after dose escalation is complete and the clinical trial has progressed to the cohort expansion phase. SB-525 is being developed as part of a global collaboration between Sangamo and Pfizer Inc. for the development and commercialization of potential gene therapy programs for hemophilia A. Ed Conner, Chief Medical Officer of Sangamo, said: "Regarding SB-525, we are pleased with the SMC's recommendation for escalation to an additional dose, which is enabled by the safety profile, the lack of immunogenicity, and the dose-dependent response observed to date across the first three dose cohorts. Our goal is to advance into the pivotal phase of development with the dose that holds the highest potential to meet the needs of patients with hemophilia A. We do not believe that others have yet presented data that would support an optimal product profile for hemophilia A gene therapy."
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CDK | Hot Stocks08:44 EDT CDK Global announces entry into ASR to purchase $260M of common stock - CDK Global announced its entry into an accelerated share repurchase, or ASR, agreement with Credit Suisse Capital to purchase $260M of the company's common stock. Under the terms of the ASR agreement, the company will make a $260M payment to Credit Suisse on November 13 and will receive from them on the same day an initial delivery of approximately 4.1M shares of the company's common stock. The final number of shares to be purchased will be based on the average of the daily volume-weighted average price of the company's common stock during the term of the ASR transaction, less a discount and subject to adjustments pursuant to the terms and conditions of the ASR agreement. At settlement, under certain circumstances, the company may be entitled to receive additional shares of the company's common stock from Credit Suisse or, under certain circumstances, the Company may be required to deliver shares of common stock or to make a cash payment, at the company's election, to Credit Suisse. The final settlement of the transaction under the ASR agreement is expected to occur during the company's fiscal quarter ending March 31, 2019.
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MRTX | Hot Stocks08:44 EDT Mirati Therapeutics presents data from Phase 2 trial of mocetinostat combination - Mirati Therapeutics announced data from the ongoing Phase 2 clinical trial of mocetinostat in combination with durvalumab in non-small cell lung cancer or NSCLC patients at the Society for Immunotherapy of Cancer 33rd Annual Meeting. As of the data cut-off date of October 2, 29 patients were evaluable for response with at least one radiographic scan. Patients had a median of two lines of previous therapy. 12/29 evaluable patients demonstrated tumor reductions. 6/29 evaluable patients demonstrated tumor reductions of greater than 30%. 5/29 evaluable patients achieved a confirmed Partial Response. 4/29 evaluable patients, including 2 responding patients, remained on treatment at the time of data cut-off. The combination has been well-tolerated and most adverse events were grade 1 or 2. The company plans to initiate a Phase 3 clinical trial comparing sitravatinib in combination with checkpoint inhibitor therapy to docetaxel in second line checkpoint inhibitor refractory NSCLC patients in 1H19. In addition, the company plans to initiate a Phase 1/2 clinical trial of MRTX849, an oral inhibitor of KRAS G12C, in patients with NSCLC, colorectal cancer, and other solid tumors that harbor the G12C mutation. Trial initiation is planned for early 2019 after the IND allowance letter is received from the FDA for the application that was filed in October.
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SMTX | Hot Stocks08:39 EDT SMTC Corp. acquires MC Assembly Holdings for $65M - SMTC Corp. and MC Assembly Holding announced that SMTC has acquired all outstanding shares of MC Assembly. The purchase price at closing was $65M, subject to certain adjustments. Additionally, the sellers are eligible to earn up to an additional $5M of consideration, contingent upon the performance of MC Assembly for the twelve calendar months ending March 31, 2019. The acquisition results in a combined company with consolidated results for the twelve months ended September 30, of approximately $323M in revenue and approximately $18M of adjusted EBITDA. The consolidated results do not reflect the potential cost savings available from the combination of the two companies. Management teams of both companies have worked collaboratively to identify $6M+ of annual cost reduction opportunities from purchasing and operational advantages and corporate and shared services redundancies that the combined company expects to implement during 2019 at a non-recurring cost of approximately $3M. The combined company will operate under the name SMTC Corporation and currently plans to continue to operate and maintain the existing facilities operated by each company. The proceeds of a new debt financing package, in combination with cash from SMTC's balance sheet, funded the transaction and related fees and expenses.
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MRTX | Hot Stocks08:39 EDT Mirati Therapeutics presents preliminary data from Phase 2 trial of sitravatinib - Mirati Therapeutics announced preliminary biomarker data from the ongoing Phase 2 clinical trial of sitravatinib in combination with nivolumab in non-small cell lung cancer patients at the Society for Immunotherapy of Cancer 33rd Annual Meeting. The ongoing Phase 2 clinical trial is evaluating the safety and efficacy of sitravatinib in combination with an anti-PD-1 immune checkpoint inhibitor, in patients who have experienced documented disease progression following prior checkpoint inhibitor therapy. Efficacy data demonstrated a higher rate of durable responses than would be expected from treatment with docetaxel, the standard of care. The presentation highlighted an initial assessment of correlative biomarkers for the 56 evaluable patients from the on-going clinical trial. The analysis demonstrated a CD8+ T effector cell response in patients who achieved a clinical benefit, suggesting a therapy-driven restoration of the anti-tumor immune response in patients who had become refractory to prior checkpoint inhibitor treatment. The data suggest that patients with high PD-L1 at baseline may be more likely to benefit from treatment with the combination although the difference was not statistically significant. There was no difference in treatment outcomes for patients based on their baseline tumor mutational burden or other baseline biomarkers.
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GSL | Hot Stocks08:38 EDT Global Ship Lease announces new long-term charter agreements - Global Ship Lease announced that Poseidon Containers, with which Global Ship Lease has entered a definitive merger agreement, has agreed five-year charters with CMA CGM for four of its 6,927 TEU containerships, Mary, Kristina, Katherine and Alexandra. The charters will deliver incremental annualized EBITDA of approximately $11M compared to third quarter 2018 contracted rates. The new charter for Mary commenced recently, and the remaining three new charters will commence upon expiry of their existing charters during the first half of 2019. The new five-year charters are expected to generate total EBITDA of approximately $135M over the five-year contract period.
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MRTX | Hot Stocks08:37 EDT Mirati Therapeutics presents data from Phase 2 trial of sitravatinib/nivolumab - Mirati Therapeutics announced preliminary biomarker data from the ongoing Phase 2 clinical trial of sitravatinib in combination with nivolumab in non-small cell lung cancer patients at the Society for Immunotherapy of Cancer 33rd Annual Meeting in Washington, D.C. The data will be presented today in a poster and also in an oral presentation on Saturday, November 10th. The ongoing Phase 2 clinical trial is evaluating the safety and efficacy of sitravatinib in combination with an anti-PD-1 immune checkpoint inhibitor, in patients who have experienced documented disease progression following prior checkpoint inhibitor therapy. Efficacy data were recently presented at the October 2018 European Society for Medical Oncology Congress. The data demonstrated a higher rate of durable responses than would be expected from treatment with docetaxel, the standard of care. Today's presentation, "Preliminary Biomarker Analysis of Sitravatinib in Combination with Nivolumab in NSCLC Patients Progressing on Prior Checkpoint Inhibitor", highlighted an initial assessment of correlative biomarkers for the 56 evaluable patients from the on-going clinical trial. Exploratory baseline and dynamic biomarker endpoints were evaluated for correlation with clinical outcomes. The analysis demonstrated a CD8+ T effector cell response in patients who achieved a clinical benefit, suggesting a therapy-driven restoration of the anti-tumor immune response in patients who had become refractory to prior checkpoint inhibitor treatment. The data suggest that patients with high PD-L1 at baseline may be more likely to benefit from treatment with the combination although the difference was not statistically significant. There was no difference in treatment outcomes for patients based on their baseline tumor mutational burden or other baseline biomarkers.
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SLS | Hot Stocks08:36 EDT Sellas Life Sciences settles counterclaims against JGB Newton - Sellas Life Sciences announced that it has agreed to a settlement with JGB Newton, regarding Sellas' counterclaims against JGB which were asserted in the litigation originally commenced by JGB. As part of the settlement, JGB has paid SELLAS approximately $6.6M in exchange for a full discharge of all claims and counterclaims asserted by SELLAS and JGB in the litigation. SELLAS and JGB have also agreed to terminate the debenture agreement and all related agreements, with JGB releasing all of its interests in the collateral for the debenture. JGB filed the litigation in connection with a senior secured debenture entered into by SELLAS' predecessor company, Galena BioPharma, Inc., prior to Galena's reverse merger with SELLAS on December 29, 2017. Sellas' counterclaims related to breach of contract by JGB, among other issues. As SELLAS previously announced, on October 23, the U.S. District Court for the Southern District of New York entered an order granting in full SELLAS' motion to dismiss the complaint brought by JGB in connection with the debenture. SELLAS' counterclaims relating to breach of contract by JGB were not dismissed, as the court found SELLAS' interpretation of the contract to be prevailing.
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GCAP | Hot Stocks08:35 EDT Gain Capital reports October operating metrics - In the retail segment in October, OTC Trading Volume was up 54.5% sequentially and up 20.1% y/y. OTC Average Daily Volume was up 34.7% sequentially and up 214.8% y/y. 12 Month Trailing Active OTC Accounts were down 1.6% sequentially and were down 4.9% y/y. 3 Month Trailing Active OTC Accounts were down 1.9% sequentially and down 13.7% y/y.
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CLAR | Hot Stocks08:35 EDT Clarus acquires assets of SKINourishment - Clarus announced the acquisition of the assets of SKINourishment. The acquisition provides an entry into the skincare category which, along with other sport-enhancing products, is a strategic focus of the company and a newly targeted high-growth potential category. SKINourishment offers organic, 100% food-grade, plant-based skin products that are safe and effective, with distribution across 37 countries. Since SKINourishment's products are made from plants and food-grade ingredients, they are cruelty-free, non-GMO, vegetarian, vegan and some are gluten free. Its products are sold under four brands-climbOn, crossFIXE, POLYN and POLYNTM baby. Clarus' initial focus will be on the launch of seven climbOn products through its global distribution platform. Financial terms of the asset acquisition were not disclosed.
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BKD | Hot Stocks08:35 EDT Macquarie Investment Management urges Brookdale holders to take action - Macquarie Investment Management announced that it has written an open letter to shareholders of Brookdale Senior Living (BKD). Macquarie believes engaging with shareholders of Brookdale in constructive dialogue can positively influence corporate behaviors and drive long-term, sustainable returns for clients. Open letter to fellow Brookdale Senior Living Inc. shareholders: "We have been shareholders of Brookdale Senior Living since December 2016 and are currently among the company's 10 largest shareholders. Brookdale's stock has fallen from a high of $38.74 in 2015 to today's price of 8.87. This represents a negative 77% return from the peak, during a period in which senior-housing real estate has increased in value. Given the financial performance at Brookdale over the last decade and the results for its stock, we believe shareholders must speak up and advocate for basic changes to its business model. We are not the first shareholder to suggest changes. Like others, we believe the case for asset monetization, or selling the company's real estate holdings, is particularly compelling. Historically, lease restrictions, such as "change of control" covenants, limited Brookdale's ability to monetize its real estate assets. Those restrictions have recently been lifted, and management has far greater flexibility. In our view, there is strong demand for senior housing assets, backed by a vibrant credit market that makes the timing right for an asset sale. Based on our recent calculations, Brookdale stock is trading at a 50% discount to the estimated value of its real estate. Undoubtedly, credit markets will not always be as strong as they are today. With Brookdale trading at a fraction of its liquidation value, we are concerned that management has not identified the clear opportunity to aggressively sell real estate holdings in an effort to stabilize the business. We believe now is the ideal time to unlock this embedded value. To summarize, we believe the path to closing Brookdale's "valuation gap" is simple: Brookdale should use its new flexibility to sell its owned real estate or sell the entire company. We are taking this action to propose fundamental strategic changes for Brookdale's management that we believe would benefit all shareholders. We urge other Brookdale shareholders to petition its board of directors and management to take swift action to unlock the substantial value that is embedded in the company's owned real estate. The views expressed represent the Manager's assessment as of the date indicated, and should not be considered a recommendation to buy, hold, or sell any security, and should not be relied on as research or investment advice."
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PSXP | Hot Stocks08:34 EDT Phillips 66 Partners announces expansion open season for Gray Open Pipeline - Phillips 66 Partners announces that Gray Oak Pipeline is launching a binding expansion open season to solicit shipper commitments for services from West Texas. The expansion open season will provide an opportunity for interested shippers to secure long-term crude oil transportation with the Gray Oak Pipeline under binding transportation services agreements. The expansion includes new takeaway capacity from Gray Oak Pipeline origination stations in West Texas to destinations in the Corpus Christi and Freeport markets. The final scope and capacity will depend on the outcome of the expansion open season. The pipeline expansion is expected to be placed in service in the fourth quarter of 2020.
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PSX | Hot Stocks08:33 EDT Phillips 66 announces open season for proposed Red Oak Pipeline - Phillips 66 announces an open season for the proposed Red Oak Pipeline, which will provide shippers the opportunity to secure crude oil transportation service from Cushing, Oklahoma, to Corpus Christi, Houston and Beaumont, Texas. The Red Oak Pipeline is expected to have an initial throughput capacity of 400,000 BPD with the ability to expand further depending on shipper interest in the open season. The pipeline is anticipated to be placed in service in the fourth quarter of 2020.
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PSX | Hot Stocks08:33 EDT Phillips 66, Bridger Pipeline announce open season for proposed Liberty Pipeline - Phillips 66 and Bridger Pipeline announce a joint open season for the proposed Liberty Pipeline, which will provide shippers the opportunity to secure crude oil transportation service from the Rockies and Bakken production areas to Corpus Christi, Texas. The Liberty Pipeline is expected to have an initial throughput capacity of 350,000 barrels per day with the ability to expand further depending on shipper interest in the open season. The pipeline is anticipated to be placed in service in the fourth quarter of 2020.
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CLDX | Hot Stocks08:33 EDT Celldex presents interim data from CDX-1140 at SITC - Celldex presented interim data from the Phase 1 dose-escalation study of CDX-1140, a fully human agonist anti-CD40 antibody. CD40, expressed on dendritic cells and other antigen presenting cells, has long been an important target for immunotherapy, as it plays a critical role in the activation of innate and adaptive immune responses. The data were presented in a poster session at the Society for Immunotherapy of Cancer, or SITC. Potent CD40 agonist antibodies have shown encouraging results in early clinical studies; however, systemic toxicity associated with broad CD40 activation has limited their dosing. CDX-1140 has unique properties relative to other CD40 agonist antibodies: potent agonist activity resulting in dendritic cell and B cell activation is independent of Fc receptor interaction, contributing to more consistent, controlled immune activation; CD40 ligand binding is not blocked, allowing potential synergistic, antigen-specific agonist activity; and the antibody promotes strong immune activation without significant adverse events in preclinical toxicology studies. Seventeen patients with solid tumors were enrolled at the time of data analysis. Four single-agent dosing cohorts have completed and enrollment to the 0.36 mg/kg monotherapy cohort is ongoing. Enrollment to the first CDX-1140/CDX-301 combination cohort is ongoing. Dose dependent biological effects consistent with CD40-mediated immune activation have been observed in the study and no maximum tolerated dose, or MTD, has been identified to date. Continued enrollment is ongoing to define the MTD and select a dose for disease-specific expansion cohorts that will be monitored for clinical activity.
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GILD | Hot Stocks08:18 EDT Gilead says data shows sofosbuvir-based regimens achieve high cure rates in HCV - Gilead Sciences announced results from studies investigating Epclusa in chronic hepatitis C virus infected patients with severe renal impairment undergoing dialysis and Harvoni in pediatric HCV patients aged three to five years, adding to the efficacy and safety profile of sofosbuvir-based regimens across diverse patient populations. Results from an open-label Phase 2 study demonstrated that treatment with the once-daily single-tablet regimen of Epclusa for 12 weeks in patients with genotype 1, 2, 3, 4 or 6 HCV and severe renal impairment undergoing dialysis resulted in cure rates of 95 percent with only two patients experiencing virologic failure. The most common adverse events were headache, fatigue, nausea, vomiting and insomnia. No patients discontinued therapy due to an adverse event. In another open-label Phase 2 study, children aged three to five years old with genotype 1 or 4 HCV infection received weight-based oral dosing of ledipasvir/sofosbuvir granules 33.75 mg/150 mg if less than 17 kg or 45 mg/ 200 mg if greater than or equal to 17 kg once-daily for 12 weeks. Overall, 97 percent of the patients were cured, and none experienced virologic failure. The most common AEs were vomiting, cough, pyrexia, rhinorrhea and streptococcal pharyngitis. One patient discontinued treatment due to an adverse event of abnormal drug taste. The use of Epclusa and Harvoni, including granules formulation, in the aforementioned patient populations is investigational; their safety and efficacy have not been established. The granule formulation is not approved. Epclusa and Harvoni are both indicated in the US for the treatment of chronic HCV infection in patients with no cirrhosis or compensated cirrhosis: Epclusa for adults with genotypes 1-6; and Harvoni for patients 12 years and older with genotypes 1, 4, 5 and 6. The US product labels for Epclusa and Harvoni each contain a Boxed Warning for the risk of hepatitis B reactivation in HCV/HBV co-infected patients. See below for US Important Safety Information. Gilead is presenting data on GS-9688, an investigational, oral selective toll-like receptor 8 agonist, one of several compounds under investigation as part of Gilead's HBV cure program. The data support continued development of GS-9688 as a potential therapeutic approach for achieving a functional cure for patients with chronic HBV infection. In the first-in-human, healthy volunteer safety study, GS-9688 was well-tolerated at single ascending doses up to 5mg and resulted in pharmacodynamic activity as demonstrated by the production of the systemic cytokines IL-1RA and IL-12p40 and by the activation of key relevant immune cells including natural killer cells and mucosal-associated invariant T cells. The most commonly reported AEs among people receiving doses up to and including 5 mg were nausea and vomiting. There were no reports of Grade 3 or higher AEs, laboratory AEs or serious adverse events and no discontinuations or deaths. In a Phase 1b safety and tolerability study of GS-9688 in HBV chronically infected patients, dose-dependent activation of the cytokines IL-12p40 and IL-1RA was demonstrated with once weekly dosing for up to 4 weeks in viremic and virally-suppressed patients. There were no reports of SAEs; the most common AEs were headache and nausea. Based on these data, GS-9688 is currently being evaluated in Phase 2 studies in patients with chronic hepatitis B. Presentations on Vemlidy add further evidence to its established safety and efficacy profile in adults with chronic HBV and compensated liver disease, including longer term data on the safety of Vemlidy in virologically suppressed HBV patients. Through three years of treatment, patients originally randomized to receive TAF continued to show an improved bone and renal safety profile compared to treatment with tenofovir disoproxil fumarate 300mg with maintained viral suppression. In a separate study in post-liver transplant patients virally suppressed on TDF-based regimens, switching to TAF maintained viral suppression in all TAF-treated patients with improvements in renal function and bone mineral density, after 48 weeks of treatment.
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SBPH | Hot Stocks08:15 EDT Spring Bank Pharmaceuticals presents additional Phase 2 ACHIEVE results at AASLD - Spring Bank Pharmaceuticals announced that principal investigators for the ongoing Phase 2 ACHIEVE trial examining the use of inarigivir soproxil for the treatment of chronic hepatitis B virus, or HBV, will present additional inarigivir results in two presentations, one oral presentation and one poster of distinction, at the American Association for the Study of Liver Disease, or AASLD, conference. Spring Bank is developing inarigivir, an orally-administered selective immunomodulator, as a potential backbone in a combinatorial treatment for chronic HBV, with a goal to accelerate and substantially increase functional cure rates in a simple, safe and selective manner. In the poster of distinction presentation the company will present data on the direct acting anti-viral, or DAA, effect of inarigivir on HBV viral replication. In vitro studies in HBV cell culture systems have demonstrated that inarigivir has the ability to prevent viral replication by inhibiting HBV replication at the level of reverse transcription and/or blocking priming or subsequent primer translocation within the viral nucleocapsid, which appears independent of the RIG-I mediated activation of IRF-3 and cytokine activation. The oral presentation will show the full 24-week clinical and virological data from the 25mg, 50mg and 100mg cohorts of inarigivir monotherapy, including sequential dosing data following the switch from inarigivir to tenofovir disoproxil fumarate. The data demonstrate a dose dependent potent anti-viral effect of inarigivir on HBV DNA with reduction of up to 2.75log10 at inarigivir 100mg and similar reductions in HBV RNA. Professor Yuen's presentation will also highlight the reduction in HBsAg in 13 predefined responder patients with a mean reduction of 0.8log10. Predictive factors for anti-viral response to inarigivir monotherapy include HBeAg negative status, baseline HBsAg concentration, baseline serum IP-10 and reduction in IP-10 during the first 12 weeks of inarigivir monotherapy.
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MNK | Hot Stocks08:14 EDT Mallinckrodt presents data on investigational agent terlipressin in HRS-1 - Mallinckrodt announced results of a pooled analysis of terlipressin clinical trial data in patients with hepatorenal syndrome type 1 at The Liver Meeting 2018. The analysis of data from two previously completed Phase 3 studies conducted in North America showed that treatment with terlipressin was associated with improved overall and transplant-free survival in HRS-1 patients with lower baseline mean arterial pressure. This effect was seen independent of HRS reversal, and may relate to a marked improvement in MAP and renal function in this patient group following administration of terlipressin. Terlipressin is being investigated for the treatment of HRS-1, a rare, acute, rapidly progressing and life-threatening complication of liver cirrhosis that leads to renal failure. The safety and effectiveness of terlipressin have not yet been established by the FDA. There are no currently approved drug therapies for HRS-1 in the U.S. or Canada. The pooled analysis of REVERSE and OT0401 clinical data showed: overall survival at 90 days in the MAP less than 65 mm Hg group was significantly higher among patients receiving terlipressin versus placebo: survival estimate was 0.680 versus 0.209, respectively. No difference in overall survival at 90 days was observed between terlipressin and placebo in the MAP greater than or equal to 65 mm Hg group.
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GILD | Hot Stocks08:14 EDT Gilead presents Phase 2 data on investigational FXR agonist GS-9674 - Gilead Sciences announced new data from the company's clinical development program for advanced fibrosis due to nonalcoholic steatohepatitis. Data presented support the ongoing development of the company's investigational compounds, evaluate the utility of noninvasive tests for the identification of patients with advanced fibrosis, and demonstrate the significant burden of disease in affected patients. Data from a Phase 2 randomized, placebo-controlled trial of the investigational, selective, non-steroidal farnesoid X receptor agonist GS-9674 will be presented. In this study, 140 NASH patients were treated with GS-9674 100 mg, GS-9674 30 mg or placebo orally once daily for 24 weeks. A decline of at least 30 percent in hepatic fat measured by magnetic resonance imaging-proton density fat fraction was observed in 38.9 percent of patients treated with GS-9674 100 mg, 14 percent treated with GS-9674 30 mg, and 12.5 percent with placebo. Improvements in liver biochemistry tests and markers of reduced bile acid synthesis were observed in the 30 mg and 100 mg arms of GS-9674-treated patients. GS-9674 was generally well tolerated; moderate to severe pruritus, or itching, occurred in 14 percent of patients in the GS-9674 100 mg arm compared to four percent in the GS-9674 30 mg and placebo arms. Changes in lipid profile and glycemic parameters did not differ between GS-9674 and placebo-treated patients. The most common adverse events in patients treated with GS-9674 were pruritus, upper respiratory tract infection, headache and fatigue. Treatment was discontinued due to adverse events in one patient treated with GS-9674 100 mg, five patients treated with GS-9674 30 mg, and two patients with placebo. A separate Phase 2 study is investigating treatment with GS-9674, the investigational apoptosis signal-regulating kinase 1 inhibitor selonsertib, and the investigational acetyl-CoA carboxylase inhibitor GS-0976 alone or in combination, in patients with advanced fibrosis due to NASH. This randomized, double-blind 52-week study will assess improvement in fibrosis without worsening of NASH, adverse events and laboratory abnormalities in approximately 350 patients. In a late-breaker session, Gilead will present an analysis of baseline data from its Phase 3 STELLAR trials of selonsertib suggesting that the use of currently available noninvasive tests can accurately identify patients with advanced fibrosis due to NASH and potentially reduce the need for liver biopsy. The use of the Fibrosis-4 index, Enhanced Liver Fibrosis test and liver stiffness measurement by FibroScan each demonstrated good sensitivity and specificity for the discrimination of advanced fibrosis due to NASH when compared to liver biopsy. When used sequentially, FIB-4 followed by FS or the ELF test accurately identified advanced fibrosis in 76-81 percent of patients while reducing the frequency of indeterminate results to as low as 13 percent. Baseline data from patients enrolled in the STELLAR Phase 3 program presented in a poster session at The Liver Meeting 2018 demonstrate the significant burden of disease among people with advanced fibrosis due to NASH. In 1,660 patients enrolled in the STELLAR trials, patient-reported outcome measures were assessed prior to treatment initiation and compared with population norms. The data demonstrate that physical health-related PRO scores of NASH patients were significantly lower than population norms. In addition, patients with cirrhosis had lower PRO scores than those with bridging fibrosis in areas including bodily pain, social functioning, and all but one domain of the disease-specific Chronic Liver Disease Questionnaire for nonalcoholic fatty liver disease and NASH.
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GILD | Hot Stocks08:12 EDT Gilead announces GS-9674 Phase 2 trial resutls, confirms Orphan Drug Designation - Gilead Sciences announced that treatment with GS-9674, an investigational, selective, nonsteroidal farnesoid X receptor, or FXR, agonist, led to significant improvements in liver biochemistry and markers of cholestasis in patients with primary sclerosing cholangitis, or PSC. Data were presented at The Liver Meeting 2018 in San Francisco. PSC is a rare, chronic condition that causes the network of ducts that drain bile from the liver to become inflamed and scarred over time. Progressive damage to the bile ducts in patients with PSC can lead to cirrhosis, liver failure, and cholangiocarcinoma. Fatigue, pruritus and abdominal discomfort are common symptoms of PSC that can greatly impact patients' quality of life. There are no approved treatments for PSC. GS-9674 was well tolerated and the incidence of Grade 2 or 3 pruritus was numerically lower with GS-9674 100 mg and 30 mg compared with placebo. There were no elevations in serum lipids. Treatment was discontinued due to adverse events in three patients treated with GS-9674 100 mg, including one discontinuation due to pruritus, and one patient with placebo. GS-9674 is an investigational compound and is not approved by the FDA or any other regulatory authority. Its safety and efficacy have not been determined. Thew company also confirms that GS-9674 was granted Orphan Drug Designation by the FDA.
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CTMX | Hot Stocks08:09 EDT CytomX Therapeutics presents CX-072 clinical translational data at SITC - CytomX Therapeutics announced that clinical translational data from PROCLAIM-072, an ongoing Phase 1/2 trial evaluating CX-072, a Probody therapeutic targeting PD-L1, was presented as a poster this morning and will be highlighted during a rapid fire oral presentation tomorrow at the 33rd Annual Meeting of The Society for Immunotherapy of Cancer being held in Washington DC. "These preliminary data provide additional proof-of concept for the Probody platform and build upon the clinical data we have presented to date showing that CX-072 appears to be performing as designed in patients," said W. Michael Kavanaugh, M.D. chief scientific officer and head of research and non-clinical development at CytomX. "These findings confirm that CX-072 is unmasked and activated and has biological activity in patient tumors while remaining predominantly masked and intact in circulation. This is another important step in understanding the full potential of our novel platform."
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LGIH | Hot Stocks08:08 EDT LGI Homes announces $50M stock repurchase program - LGI Home announced that its board authorized a stock repurchase program, pursuant to which the company may purchase up to $50M of shares of its common stock through open market transactions, privately negotiated transactions or otherwise in accordance with applicable laws. The timing, amount and other terms and conditions of any repurchases will be determined by the company's management at its discretion based on a variety of factors, including the market price of the company's common stock, corporate considerations, general market and economic conditions and legal requirements. The stock repurchase program may be modified, discontinued or suspended at any time. The company intends to fund the stock repurchase program through cash on hand, future cash flow from operations and its revolving credit facility.
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ALNY | Hot Stocks08:08 EDT Alnylam says givosiran showed sustained clinical activity in Phase 1/2 OLE study - Alnylam Pharmaceuticals announced that the Company presented updated results from the ongoing Phase 1/2 open-label extension study of givosiran, an investigational RNAi therapeutic, targeting aminolevulinic acid synthase 1 for the treatment of acute hepatic porphyria. As of the data cut-off date of June 7, 2018, a robust treatment effect was maintained in givosiran-treated patients with continued dosing in the Phase 1/2 OLE study, with a mean time on treatment of 13.6 months and total time on treatment across the Phase 1 and OLE studies of up to 25 months. Monthly dosing at 2.5 mg/kg led to sustained lowering of aminolevulinic acid and porphobilinogen toward normal levels, with a mean reduction from baseline of 87 and 83 percent, respectively, at 12 months. In patients who received givosiran during the Phase 1 study and continued with givosiran dosing in the OLE study, mean reductions in annualized attack rate of 93 percent and annualized hemin use of 94 percent were observed, relative to pre-treatment results. Similarly, patients in the placebo arm of the Phase 1 study crossing over to givosiran treatment in the OLE study experienced mean reductions in AAR of 95 percent and annualized hemin use of 98 percent. Seven of sixteen patients achieved an AAR of zero with a mean of 11.3 months on treatment; the average AAR during the run-in period for these seven patients was 15.2. Serious adverse events were reported in four patients. Previously reported SAEs included: a patient with an upper extremity deep vein thrombosis, assessed as unlikely related to study drug by the investigator; and one patient who had an anaphylactic reaction after the third dose of givosiran, assessed as definitely related to study drug, which resolved with medical management. New SAEs included: a patient with two episodes of pyrexia related to a suspected Port-a-Cath infection and chlamydia bronchitis, assessed as unlikely related to study drug; and one patient with a change in mental status due to a possible glucocorticoid toxicity from an acute bacterial sinusitis, both of which were assessed as unlikely related to study drug. Adverse events occurring in three or more patients included abdominal pain, fatigue, injection site erythema, nausea, myalgia, diarrhea, headache, and nasopharyngitis. Six patients had injection site reactions, all mild to moderate. No clinically significant increases in liver function tests or lipase levels were noted with continued dosing in the OLE study.
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CUE | Hot Stocks08:07 EDT Cue Biopharma presents foundational data on Immuno-STAT platform and CUE-101 - Cue Biopharma announced preclinical results demonstrating the potential of its Immuno-STAT platform and lead candidate CUE-101. In the study, CUE-101 demonstrated selective binding and preferential activation and expansion of antigen-specific T cells, dose-dependent effector cytokine production and inhibition of tumor growth both as a monotherapy and in combination with a PD-1 inhibitor. The poster, entitled "CUE-101, a novel Fc fusion protein comprised of HLA-A*0201-bound HPV16 E7 peptide and IL-2, for selective targeting and expansion of anti-tumor T cells for treatment of HPV-driven malignancies," (P185) is being presented today during the poster session at the Society for Immunotherapy of Cancer's 33rd Annual Meeting being held in Washington, D.C. "This study highlights the unique qualities and potential of our Immuno-STAT platform to selectively activate antigen-specific T cells to generate robust targeted immune responses in one of our areas of focus, oncology," said Anish Suri, Ph.D., Senior Vice President and Chief Scientific Officer of Cue Biopharma. "CUE-101 demonstrated several key features in this study including selective targeting of antigen-specific T cells and preferential proliferation and expansion of those T cells both in vivo and in human peripheral blood mononuclear cells. We also showed in preclinical models that a murine surrogate, designated mCUE-101, inhibits tumor growth both as a monotherapy, and demonstrating significant synergy when combined with a PD-1 inhibitor."
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ABBV | Hot Stocks08:06 EDT AbbVie presents HCV patient landscape with new mapping website - AbbVie will present data from two studies that assessed HCV screening and diagnosis practices and linkage to care in the U.S. at The Liver Meeting 2018. The two studies are part of a comprehensive dataset that can now be accessed through MappingHepC.com, a new interactive online resource that features national and state-level data on HCV screening, diagnosis and treatment. AbbVie analyzed two large national laboratory datasets including over 17 million HCV antibody tests and 1.5 million HCV RNA tests in US patients between 2013 and 2016.1 MappingHepC.com relies on actual patient HCV antibody and confirmatory RNA test results.
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RWLK | Hot Stocks08:06 EDT ReWalk Robotics announces placement of 500th exoskeleton system - ReWalk Robotics announced that the company has placed its 500th robotic exoskeleton medical device. The majority of these devices are personal systems used by individuals with spinal cord injury in their homes and communities, while others are located in rehabilitation centers to evaluate and train potential new device owners. The first ReWalk device was placed in 2011 to the Vatican Hospital in Rome, and it became the first exoskeleton to be cleared by the FDA for sale in the United States in June 2014. To continue its growth, the Company is focused on expanding insurance coverage of exoskeletons for all persons with spinal cord injury and has helped develop national coverage policies with payers in several countries, including Germany, Italy and the U.S. Department of Veterans Affairs in the U.S. The Company continues to work with payers on individual system procurements as well as the development of broad private coverage policies and additional national coverage policies for eligible beneficiaries. To date, 38 different payers in the United States and 39 in Germany have provided positive coverage decisions for ReWalk Personal systems to their clients.
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OMED | Hot Stocks08:05 EDT OncoMed announces early clinical data for anti-TIGIT antibody - OncoMed Pharmaceuticals announced initial results from the Phase 1a dose escalation portion of a Phase 1a/b trial of etigilimab, the company's anti-TIGIT antibody. TIGIT is a next generation checkpoint receptor shown to block T-cell activation and the body's natural anti-cancer immune response. OncoMed's anti-TIGIT checkpoint inhibitor candidate is an IgG1 monoclonal antibody which binds to the human TIGIT receptor on T-cells with a goal of improving the activation and effectiveness of T-cell and NK cell tumor-killing activity. The data were presented today at the Society for Immunotherapy of Cancer meeting taking place in Washington, D.C. "These data indicate that etigilimab was well-tolerated by patients and showed modulation of specific subsets of peripheral T cells," said John Lewicki, Ph.D., President and Chief Executive Officer of OncoMed. "The decrease in peripheral Tregs and observations of stable disease in certain patients are consistent with the expected mechanisms of our IgG1 anti-TIGIT antibody." The company is currently enrolling a single agent Phase 1a expansion cohort in select tumor types. Concurrently, the company is also enrolling the phase 1b portion of the trial where escalating doses of etigilimab are given in combination with nivolumab in the treatment of patients with solid tumors who have progressed after treatment with anti-PD1 or anti-PD-L1. The trial will define a dosing regimen that could provide the basis for expanded studies of etigilimab in combination with anti-PD1.
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MTEM | Hot Stocks08:05 EDT Molecular Templates presents study on PD-L1 ETB with AST at SITC - Molecular Templates announced the presentation of a poster on its PD-L1 ETB with Antigen Seeding Technology at the ongoing Society for Immunotherapy of Cancer's 33rd Annual Meeting, currently taking place in Washington D.C. Antigen Seeding Technology represents a novel immune-oncology approach leveraging the novel mechanism of action of Molecular Templates' ETB technology. ETBs engineered with Antigen Seeding Technology are capable of delivering viral antigens as a payload inside the target tumor, resulting in the antigens being presented on the cell surface of the tumor cells in complex with MHC-1. ETB therapeutics incorporating antigen seeding are designed to work through dual mechanisms of action by redirecting a high avidity, pre-existing antigen-specific cytotoxic T cell response to the tumor while at the same inducing cell death via the enzymatic and permanent destruction of ribosomes. Coupling two distinct mechanisms of tumor cell killing into one ETB molecule provides the potential to increase target penetrance, expand a prolonged immune response, and overcome tumor resistance. The poster, titled "Identification and Functional Profiling of PD-L1 Targeted Engineered Toxin Bodies for Antigen Seeding Technology and Redirection of T cell Response to Tumors" summarizes a series of preclinical experiments conducted by Molecular Templates to create PD-L1 targeted ETBs that have antigen seeding properties and to analyze the mechanisms by which they can kill cancer cells.
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ALPN | Hot Stocks08:04 EDT Alpine says 'on track' to initiate human clinical trials of ALPN-202 in 4Q19 - Alpine Immune Sciences announced advancements in the company's oncology program. Following promising preclinical data presented at the Society for Immunotherapy of Cancer 33rd Annual Meeting in Washington, D.C., the company remains on track to initiate human clinical trials of ALPN-202, a PD-L1/CTLA-4 dual antagonist with PD-L1 dependent CD28 costimulation, in 4Q19. Alpine presented the results of a preclinical study of ALPN-202 in a poster session today, strongly supporting the proposed mechanism of action of ALPN-202 via activation of the immune system in a differentiated way from current checkpoint therapies. ALPN-202 is a novel molecule designed to block the inhibitory immune checkpoints PD-L1 and CTLA-4 while providing PD-L1 dependent T cell activation via the CD28 costimulatory pathway. It has previously been demonstrated to have efficacy in an MC38-based colorectal cancer model, superior to the FDA-approved PD-L1 inhibitor durvalumab. Today's poster correlates these findings with superior intratumoral immune cell infiltration and effector gene signatures, as well as favorable changes in T cell receptor profiles, consistent with ALPN-202's proposed multi-modal mechanism of action.The preclinical study evaluated the anti-tumor responses of ALPN-202 compared with durvalumab in mice implanted with human PD-L1 transduced MC38 tumors. Results showed ALPN-202: Produced dose-dependent anti-tumor responses, including potent single-dose activity; Induced a greater tumor inflammation gene signature than durvalumab; Induced increased T cell infiltration and T cell-related effector gene signatures compared to durvalumab; Promoted both increased T cell receptor clonality and richness, consistent with ALPN-202's multiple mechanisms of action. In a second preclinical study, Alpine used its variant immunoglobin domain platform to engineer novel NKp30/ICOSL vIgD fusion proteins. The resulting therapeutic is designed to agonize two T cell costimulatory receptors ICOS and CD28 only in the presence of B7-H6, a tumor antigen overexpressed in certain cancer types such as some forms of esophageal, kidney, rectal, and stomach cancers. Results showed the NKp30-ICOSL vIgD-Fc fusion proteins: Conferred potent T cell costimulation in vitro, with enhanced T cell proliferation and cytokine production only in response to B7-H6-expressing target cells. In contrast, ICOSL and NKp30 vIgDs alone in the absence of B7-H6 were not inflammatory. Demonstrated efficacy in a B7-H6-positive CT26 mouse colon cancer model, especially when administered in combination with a PD-1 inhibitor. The proteins were not effective on a B7-H6-negative parental CT26 tumors, demonstrating target specificity.
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SKYW | Hot Stocks08:04 EDT SkyWest reports combined October traffic - SkyWest reported 146,200 block hours in October 2018, compared to 154,500 block hours in October 2017, a decrease of 8,300 or 5.4%. The net decrease was consistent with SkyWest's fleet transition plan to improve the mix of aircraft in its fleet. The year-over-year net change was primarily driven by approximately 8,700 additional block hours from its E175 aircraft (includes the E175 aircraft and the E175 SC aircraft) and a decrease of approximately 17,000 block hours from its other aircraft types. In October 2018, SkyWest's E175 aircraft represented approximately 28% of SkyWest's total block hour production for the month compared to approximately 21% for the month of October 2017. SkyWest reported 1,470,000 block hours for year-to-date October 2018, compared to 1,544,000 block hours year-to-date October 2017, a decrease of 74,000, or 4.8%. This net change was primarily driven by approximately 69,000 additional block hours from its E175 aircraft and a decrease of approximately 143,000 block hours from its other aircraft types. SkyWest had 85,200 departures in October 2018 compared to 91,900 in October 2017, a decrease of 6,700, or 7.3%.
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MPAA | Hot Stocks08:03 EDT Motorcar Parts to delay filing of Q2 10-Q - Motorcar Parts of America announced the company will delay filing of its fiscal 2019 second quarter 10-Q and planned conference call scheduled for today to continue evaluating its accounting policies related to new business contracts.
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ADRO NVS | Hot Stocks07:46 EDT Aduro Biotech presents preliminary data from ADU-S100 trial at SITC - Aduro Biotech (ADRO) announced presentation of preliminary data from its ongoing Phase 1 dose-finding study of ADU-S100, a novel STING pathway activator, at SITC's 33rd annual meeting. Aduro and collaborator Novartis (NVS) embarked on this first-in-human trial as a first step in characterizing the safety profile and mechanism of ADU-S100 and its ability to activate the STING pathway. The Phase 1 dose escalation and dose expansion clinical trial is designed to evaluate the safety, tolerability and clinical activity of ADU-S100 in patients with advanced, metastatic treatment-refractory solid tumors or lymphomas. In this multicenter, open-label trial, ADU-S100 is administered intratumorally on days 1, 8 and 15 of a 28-day cycle. The trial has enrolled 41 patients, with 40 patients evaluated for response. The median number of prior anti-cancer treatments was four. More than half of patients received prior therapy with a checkpoint inhibitor. More than 20 types of cancer have been treated in this trial, including Merkel cell, parotid gland, colorectal, endometrial, ER+ and triple-negative breast cancer, esophageal, collecting duct carcinoma, ovarian, Hodgkin's disease, hemangioepithelioma and other cancers. Doses of 50-3200 mcg have been explored in this presentation; enrollment is ongoing for additional patient cohorts. No dose-limiting toxicities have been reported at these dose levels. The most common treatment-related adverse events, or TRAEs, were pyrexia, injection site pain and headache. Grade 3/4 TRAEs included increased lipase and elevated amylase, tumor pain, dyspnea, respiratory failure and injection site reaction. Importantly, increases in key systemic cytokines, including IL-6, MCP-1 and IFN-b, were observed after administration, indicating target engagement of ADU-S100 and activation of the STING pathway. Two of the 40 patients treated had a partial response, or PR, - one patient with Merkel cell carcinoma and one patient with parotid gland cancer who had received prior anti-PD-1 therapy. 11 patients achieved stable disease, or SD, including five patients who had received prior checkpoint inhibitor therapy. Three patients with SD remain on study and continue to receive treatment, including one patient with collecting duct carcinoma who has been on study for greater than one year. On-treatment tumor biopsies showed increases in CD8+ T cells in injected tumors in a subset of patients, including those with Merkel cell, collecting duct and esophageal carcinomas. Aduro and Novartis are continuing to evaluate additional pathology and other biomarkers to assess the pharmacological activity of ADU-S100 in these patients.
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TRCO | Hot Stocks07:22 EDT Tribune Media says not providing financial guidance for the remainder of 2018
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TRCO | Hot Stocks07:20 EDT Tribune Media reports Q3 adjusted EBITDA up 14% to $136.8M
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TRCO | Hot Stocks07:20 EDT Tribune Media CEO says 'very pleased' with Q3 revenue, adjusted EBITDA - "We are very pleased with our record third quarter revenue and Adjusted EBITDA which reflect the strong operational year we are having," said Peter Kern, Tribune Media's Chief Executive Officer. "We drove share gains in political and core advertising along with reaping the benefits of unprecedented political spending and stronger core advertising in our markets. Net of displacement, we estimate core advertising growth would have been in positive territory for the quarter, which is a significant improvement compared to the first half of the year. This robust advertising performance along with continued growth in retransmission and carriage fees and diligent focus on costs produced a terrific third quarter. We are proud of the work our teams have done during this time, and we look forward to a strong finish to the year."
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ATRS | Hot Stocks07:18 EDT Antares Pharma announces data presentation at SMSNA - Antares Pharma announced that data from the 26-week Phase 3 study of the safety and tolerability of XYOSTED will be presented as a moderated poster presentation on Friday November 9 at the 24th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America. The poster entitled "Effect of Testosterone Enanthate on 24-hour Ambulatory Blood Pressure is Less in Patients with Hypertension at Baseline" will be presented by Mohit Khera, MD, Laboratory for Andrology Research, Baylor College of Medicine, Houston Tx. The submission was among a select group of key abstracts awarded the distinction of a moderated poster presentation. The Phase 3, 26-week, dose-blind, multicenter trial of XYOSTED, a proprietary, pre-filled subcutaneous testosterone enanthate auto-injector administered weekly, examined 133 hypogonadal adult men with baseline testosterone evels of less than300 ng/dL. Patients received 75 mg of testosterone enanthate administered via auto injector once-weekly for 6 weeks. At week 7, dose adjustments were conducted according to a simple titration scheme if necessary and were based on week-6, pre-dose blood levels in the patients. The XYOSTED clinical program included a rigorous ambulatory blood pressure monitoring study to fully characterize the potential side effects of testosterone replacement on blood pressure.
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ONCY | Hot Stocks07:14 EDT Oncolytics announces presentation of pelareore and upregulation of PD-L1 - Oncolytics Biotech announced that data will be presented demonstrating pelareorep's ability to upregulate PD-L1 during infection of prostate cancer cells. The presentation is taking place at the Society for Immunotherapy of Cancer, SITC, 2018 Annual Meeting, November 7-11 in Washington, D.C. The presentation, authored Dr. Hardev Pandha, Professor of Medical Oncology, the University of Surrey, et al., is titled "Reovirus infection of prostate cancer induces upregulation of the negative regulators PD-L1 and BTLA". "This study has clearly confirmed that oncolytic virotherapy is able to create an inflamed phenotype and sensitize the tumor to immune checkpoint blockade," said Dr. Pandha. "The proinflammatory effects of viral oncolysis may stem from its attraction and activation of natural killer cells, which through the production of chemokines in the tumour, control the levels of stimulatory dendritic cells. This then primes the effector T-cells, increasing the responsiveness of prostate tumours to anti-PD-1 immunotherapy."
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ADNT | Hot Stocks07:13 EDT Adient CEO says 'confident' challenges being addressed - CEO Doug DelGrosso said, "I'm confident the challenges that impacted Adient's FY2018 results are being addressed. The team is focused on executing our transformation plan to drive improved profitability, cash flow, and returns to our shareholders."
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CRSP | Hot Stocks07:12 EDT Crispr Therapeutics expands license agreement with MaxCyte to oncology - Crispr Therapeutics and MaxCyte announced the expansion of their existing relationship by entering into a non-exclusive commercial license agreement that will allow Crispr Therapeutics to deploy MaxCyte's flow electroporation technology to develop Crispr/Cas9-based therapies in immuno-oncology. The expanded relationship builds on an existing agreement announced in March 2017 which allowed for the development of commercial therapeutics for hemoglobin-related diseases. Under the terms of the new license agreement, Crispr Therapeutics will obtain non-exclusive development and commercial-use rights to MaxCyte's cell engineering platform to develop immuno-oncology cell therapies. MaxCyte will supply its technology to Crispr Therapeutics as part of the enabling technology license agreement and will receive milestone and sales-based payments in addition to other licensing fees.
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HUSA | Hot Stocks07:10 EDT Houston American Energy provides update on San Andres prospect - Houston American Energy announced an update on the drilling plans for the San Andres prospect. As previously reported, the company entered into an agreement to acquire a 12.5% working interest in a prospect covering approximately 650 gross acres (81.25 new mineral acres) in Yoakum County, TX. The company has been notified by the prospect operator that unanticipated issues that had delayed drilling operations have been resolved and the drilling of the first well is expected to commence by year end 2018. The initial prospect is located on the Northwest Shelf of the Midland Basin. The prospect is comprised of the "Exploration" component of the San Andres Formation with well operations planned to use horizontal laterals and fracture stimulation. The initial proposed well is a 4,620-foot horizontal exploration well targeting the San Andres Formation. The operator estimates that the prospect could ultimately be developed with six additional horizontal wells as leased. "If the initial wells perform in line with our expectations, we plan to continue the pursuit of additional opportunities in Yoakum County. Given the experience of existing operators, we believe we can achieve substantial production while bringing down costs as compared to typical Permian Basin wells," stated Jim Schoonover, interim CEO of Houston American Energy.
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ESCA | Hot Stocks07:07 EDT Escalade Sports acquires Victory Tailgate, terms not disclosed - Escalade Sports, a wholly owned subsidiary of Escalade, announced that it has acquired Victory Tailgate, a brand known for its premium licensed and custom tailgating games. The acquisition will significantly strengthen Escalade Sports' leadership in the tailgating and lawn games' categories while providing exciting new opportunities within the sports licensing and customization space. Escalade Sports expects the acquisition of Victory Tailgate to be accretive to its business results beginning in 2019.
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ADNT | Hot Stocks07:05 EDT Adient says 2018 challenges 'to have significant impact in fiscal 2019'
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INVA | Hot Stocks07:05 EDT Innoviva, GSK say EC authorises expanded label for once-daily Trelegy Ellipta - GlaxoSmithKline (GSK) and Innoviva (INVA) announced that the European Commission has authorised an expanded label for once-daily Trelegy Ellipta, recognising its effect on exacerbations and making it the first single inhaler triple therapy indicated for patients with moderate to severe chronic obstructive pulmonary disease not adequately treated with dual bronchodilation or with an inhaled corticosteroid and a long-acting beta2-agonist.
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LIN PSX | Hot Stocks07:04 EDT Praxair signs new long-term hydrogen supply agreement with Phillips 66 - Praxair, a wholly-owned subsidiary of Linde (LIN), has reached an agreement with Phillips 66 (PSX) to supply high-purity hydrogen to the company's Sweeny Refinery located in Old Ocean, Texas, starting in early 2021. Praxair will extend its 310-mile U.S. Gulf Coast hydrogen pipeline system, which currently runs from Freeport, Texas to Lake Charles, Louisiana, to connect with the Sweeny Refinery. The company will also build, own and operate a new world-scale steam methane reformer that will connect to the pipeline system at a location still to be determined. The new SMR will supply Phillip's Sweeny Refinery, as well as meet the hydrogen demands of new customers. Upon expected completion in early 2021, this will be the largest hydrogen production unit in the U.S. The unit, which will have a state-of-the-art process design, will increase Praxair's Gulf Coast hydrogen capacity to more than 1.5 billion cubic feet per day.
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REDU | Hot Stocks07:04 EDT Rise Education says CFO Chelsea Qingyan Wang to resign due to personal reasons - RISE Education Cayman announced that Chelsea Qingyan Wang has decided to resign from her role as the company's CFO, due to personal reasons. Jiandong Lu will assume the role of the CFO while retaining her position as the COO of the company. Chelsea Wang will remain with the company until December 31, 2018 to ensure a smooth transition.
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CLMT | Hot Stocks07:04 EDT Calumet Specialty Products lowers FY18 CapEx view to $70M-$80M
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HEES | Hot Stocks07:02 EDT H&E Equipment appoints Bradley Barber as CEO to succeed John Engquist - H&E Equipment Services announced the appointment of Bradley Barber as CEO, president and a director of the company, effective January 1, 2019. Barber will succeed current CEO John Engquist, who has been appointed executive chairman of the Board of Directors, effective January 1, 2019. Gary Bagley, current chairman of the Board, will remain a director of the company.
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ADNT | Hot Stocks07:01 EDT Adient suspends quarterly cash dividend
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MRK | Hot Stocks06:58 EDT Merck reports data on Keytruda combination with Lenvima for three tumor types - Merck and Eisai, headquartered in Tokyo, announced results from presentations of new data and analyses of Lenvima, a kinase inhibitor discovered by Eisai, in combination with Merck's anti-PD-1 therapy Keytruda in three different tumor types - metastatic non-small cell lung cancer, metastatic melanoma and metastatic urothelial carcinoma. In the interim analyses of the studies across three tumor types, the Lenvima and Keytruda combination demonstrated "encouraging" anti-tumor activity. These data support further evaluation of the combination. Lenvima and Keytruda are not approved for use in combination in any cancer types today. The primary endpoint of the Phase 1b study was to determine the maximum tolerated dose of Lenvima and Keytruda in combination. The primary endpoint of the Phase 2 portion is objective response rate at week 24. For the Phase 1b/2 trial in NSCLC, the primary endpoint of ORR at week 24 per irRECIST was 33.3%. Grade 3 treatment-related adverse events occurred in 10 patients, 48%, and Grade 4 TRAEs occurred in one patient. There was one treatment-related death. For the Phase 1b/2 trial in advanced melanoma, the primary endpoint of ORR at week 24 per irRECIST was 47.6%. All patients experienced at least one TRAE. Grade 3 or 4 TRAEs occurred in 14 patients, 67%. There were no treatment-related deaths. For the Phase 1b/2 trial in urothelial cancer, the primary endpoint of ORR at week 24 per irRECIST was 25%. Eighteen patients, 90%, experienced TRAEs. There was one treatment-related death.
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KCAP | Hot Stocks06:49 EDT KCAP Financial announces sale of wholly-owned asset management subsidiaries - KCAP Financial announced that it has entered into an agreement with LibreMax Intermediate Holdings under which KCAP's wholly-owned asset management subsidiaries, Katonah Debt Advisors, L.L.C., Trimaran Advisors, L.L.C., and Trimaran Advisors Management, L.L.C., will be acquired by LibreMax through mergers with wholly-owned subsidiaries of LibreMax. Total consideration for the transaction, including accrued income and expenses, shall be $37.9M in cash. KCAP's Board of Directors has unanimously approved the agreement. The transaction is expected to close in 2018. The transaction is subject to customary closing conditions and approvals.
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NWY RTW | Hot Stocks06:48 EDT New York & Co. to change name to RTW Retailwinds on November 19 - New York & Company (NWY) announced that it will be changing its name to RTW Retailwinds (RTW) effective Monday, November 19, 2018. The company's common stock will begin trading under the new name on the New York Stock Exchange as of the opening of trading on Tuesday, November 20, 2018. In celebration, RTW Retailwinds is scheduled to ring the Opening Bell at the NYSE. In connection with the name change, the company's ticker symbol for its shares of common stock will change to "RTW" and the CUSIP number for the company's common stock will change to 74980D 100, each as of the effective time.
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BRS | Hot Stocks06:41 EDT Bristow Group to combine with Columbia Helicopters in $560M transaction - Bristow Group announced that it has signed a definitive agreement to combine with privately-held Columbia Helicopters for $560M. Columbia will be designated as an unrestricted subsidiary under the Columbia name and air operating certificate, or AOC. Bristow expects the complementary transaction to strengthen the company's operational and consolidated financial profile by delivering adjusted EBITDA and cash flow accretion; reducing consolidated net leverage; diversifying the combined company's fleet and customer base; expanding its addressable market, especially in the U.S. government sector; and producing significant incremental revenue opportunities. Columbia is a player in the heavy-lift helicopter operations and trusted in maintenance, repair and overhaul services, with global operations servicing end-markets that include defense, firefighting, onshore oil and gas, infrastructure and forestry. For the twelve months ended September 30, Columbia recorded revenues of approximately $281M and adjusted EBITDA of approximately $117M. Columbia's fleet of operating helicopters is comprised of 21 high return tandem rotor Vertol 107 and Chinook CH-234 / CH-47D; with additional non-operational airframes available for deployment with minimal capital expenditure. Columbia also has full MRO and certification capabilities. Together, the companies will have 304 operating aircraft and an enhanced platform to provide comprehensive aviation mission services to its expanded client base. Bristow's customer base will be significantly more diverse geographically and by end-market, with contributions from the oil and gas industry reduced to 58% of pro forma revenue for the trailing twelve-month period. Columbia generates significant contracted revenue streams from the U.S. government and the transaction is expected to more than double the combined annual adjusted EBITDA on a consolidated basis. Prior to synergies, Columbia is expected to generate $125M-$130Mof adjusted EBITDA for the twelve-month period ending March 30, 2019 and $100M-$105M of adjusted EBITDA less capital expenditures, which are primarily related to heavy aircraft maintenance capital expenditures. Bristow believes it will be able to utilize its existing net operating losses to optimize the combined company tax position. The combined company expects to achieve annual cost savings, including utilizing Columbia's MRO capabilities to reduce Bristow's maintenance expenses. The company expects significant opportunity to leverage its global network of AOCs to bring Columbia's capabilities to more global markets and expand Columbia's addressable market to include additional infrastructure and firefighting customers. In addition, the company expects to capitalize on Columbia's strong past performance with the U.S. government and Cargo Airlift Review Board certification to utilize Bristow's available aircraft in U.S. government work. Columbia's relationships and reputation in government end-markets and Bristow's fleet and capabilities position the combined company to be competitive on contract opportunities currently not available to either standalone entity. Under the terms of the agreement, Bristow will acquire 100% of the equity interests of Columbia for $560M from the Lematta family and current management. For the twelve months ended September 30, Columbia recorded revenue of approximately $281M and adjusted EBITDA of approximately $117M, resulting in a transaction multiple of 4.8x adjusted EBITDA, excluding the impact of estimated operational and cost synergies. Columbia will be designated as an unrestricted subsidiary and will be fully consolidated on the Bristow financial statements upon transaction close. Jonathan Baliff will serve on the Columbia board as a representative of Bristow upon close of the transaction. The transaction will be funded through a combination of debt, convertible debt, newly issued common shares to the Lematta family and existing Columbia management and cash from Bristow's balance sheet. Bristow has secured fully-committed debt and convertible debt financing for the transaction. The Lematta family and existing Columbia management, which is committed to leading the Columbia operating subsidiary, will roll over $77M of their current ownership into Bristow common stock, up to a maximum of approximately 7.1M shares. Bristow remains focused on deleveraging and maintaining a strong liquidity position. The transaction is expected to close prior to December 31 and is subject to customary closing conditions including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Act, the satisfaction of certain additional conditions relating to regulatory matters, the receipt of certain designated consents, and other customary closing conditions. Bristow will remain headquartered in Houston, Texas. Columbia will remain headquartered in Aurora, Oregon.
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AXP | Hot Stocks06:40 EDT American Express: PBOC grants approval for clearing, settlement license in China - American Express was notified that the People's Bank of China has granted preparatory approval for a clearing and settlement license in mainland China. American Express can now begin building a network business to process domestic, RMB transactions through its joint-venture in mainland China. American Express has formed a joint-venture with Chinese fintech services company LianLian to build a network business that will enable charges on American Express branded cards to be cleared and settled domestically by the joint-venture. The joint-venture is registered as Express Technology Services Company.
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STNE... | Hot Stocks06:17 EDT Berkshire Hathaway takes 11.3% passive stake in StoneCo - Warren Buffett's Berkshire Hathaway (BRK.A, BRK.B) disclosed an 11.3% passive stake in StoneCo (STNE). The stake represents over 14.1M shares. The filing with the SEC does not allow for activism. StoneCo is a provider of financial technology solutions in Brazil.
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RDNT | Hot Stocks06:05 EDT RadNet reports Q3 MRI volume up 5% - For the third quarter of 2018, as compared with the prior year's third quarter, MRI volume increased 5.0%, CT volume increased 7.9% and PET/CT volume increased 14.0%. Overall volume, taking into account routine imaging exams, inclusive of x-ray, ultrasound, mammography and other exams, increased 3.5% over the prior year's third quarter. On a same-center basis, including only those centers which were part of RadNet for both the third quarters of 2018 and 2017, MRI volume increased 0.1%, CT volume increased 1.5% and PET/CT volume decreased 2.7%. Overall same-center volume, taking into account routine imaging exams, inclusive of x-ray, ultrasound, mammography and other exams, increased 0.8% compared with the prior year's same quarter.
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FB | Hot Stocks06:01 EDT Facebook says has removed over 14M pieces of terrorist content this year - Monika Bickert, Global Head of Policy Management, and Brian Fishman, Head of Counterterrorism Policy at Facebook, say the company has removed over 14M pieces of terrorist content this year and median time to take action is less than two minutes in Q3. "In Q2 2018, we took action on 9.4 million pieces of content related to ISIS, al-Qaeda, and their affiliates, the majority of which was old material surfaced using specialized techniques. In Q3 2018, overall takedowns of terrorist content declined to 3 million, of which 800,000 pieces of content were old, because our efforts to surface and remove old content on the platform in the second quarter had proven effective. In both Q2 and Q3 we found more than 99% of the ISIS and al-Qaeda content ultimately removed ourselves, before it was reported by anyone in our community. These figures represent significant increases from Q1 2018, when we took action on 1.9 million pieces of content, 640,000 of which was identified using specialized tools to find older content... Our overall enforcement effort was significantly better in Q2 2018 than it was previously, even though our median time to take action was 14 hours. By Q3 2018, the median time on platform decreased to less than two minutes, illustrating that the new detection systems had matured." Reference Link
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TSM | Hot Stocks05:53 EDT TSMC reports October revenue NT$101.55B, up 7.4% y/y - TSMC announced its net revenues for October 2018: On a consolidated basis, revenues for October 2018 were approximately NT$101.55B, an increase of 7% from September 2018 and an increase of 7.4% from October 2017. Revenues for January through October 2018 totaled NT$843.25B, an increase of 6.2% compared to the same period in 2017.
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BDRBF | Hot Stocks05:44 EDT Bombardier, Akiem sign contracts to supply a total of 33 TRAXX locomotives - Akiem Bombardier Transportation have signed two contracts under frame contracts to deliver a total of 33 BOMBARDIER TRAXX locomotives. Based on their list price, the two firm orders are valued at a combined total of $128M. Scheduled for delivery between 2019 and 2021 at the latest, the 33 TRAXX locomotives will consist of a mix of TRAXX MS 2, TRAXX AC 3 and TRAXX DC3 locomotives.
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IIVI FNSR | Hot Stocks05:27 EDT II-VI to acquire Finisar for $26 per share in cash/stock deal valued at $3.2B - II-VI (IIVI) and Finisar (FNSR) announced that they have entered into a definitive merger agreement under which II-VI will acquire Finisar in a cash and stock transaction with an equity value of approximately $3.2B. Under the terms of the merger agreement, which has been unanimously approved by the Boards of Directors of both companies, Finisar's stockholders will receive, on a pro-rated basis, $15.60 per share in cash and 0.2218x shares of II-VI common stock, valued at $10.40 per share based on the closing price of II-VI's common stock of $46.88 on November 8, 2018. The transaction values Finisar at $26.00 per share, or approximately $3.2B in equity value and represents a premium of 37.7% to Finisar's closing price on November 8, 2018. Finisar shareholders would own approximately 31% of the combined company. The combination of II-VI and Finisar would unite two innovative, industry leaders with complementary capabilities and cultures to form a formidable industry leading photonics and compound semiconductor company capable of serving the broad set of fast growing markets of communications, consumer electronics, military, industrial processing lasers, automotive semiconductor equipment and life sciences. Together, II-VI and Finisar will employ over 24,000 associates in 70 locations worldwide upon closing of the transaction. On a pro forma basis, the combined company had approximately $2.5B of annual revenue. The combined broad base of talent, technology and manufacturing is expected to enhance the ability to better address near-to medium-term opportunities and accelerate revenue growth. The combined company expects to realize $150M of run-rate cost synergies within 36 months of closing. Synergies are expected to be achieved from procurement savings, internal supply of materials and components, efficient research and development, consolidation of overlapping costs and sales and marketing efficiencies. The transaction is expected to drive accretion in Non-GAAP earnings per share for the first full year post close of approximately 10% and more than double that thereafter. II-VI intends to fund the cash consideration with a combination of cash on hand from the combined companies' balance sheets and $2 billion in funded debt financing. The transaction is expected to close in the middle of calendar year 2019, subject to approval by each company's shareholders, antitrust regulatory approvals and other customary closing conditions.Upon closing of the transaction, Dr. Mattera will continue to serve as President and CEO of the combined company. In addition, in connection with the closing of the transaction, three Finisar board members will be appointed to the II-VI board, which will be expanded to 11 directors.
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IIVI FNSR | Hot Stocks05:25 EDT II-VI to acquire Finisar for $26 per share in cash/stock deal valued at $3.2B
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JAZZ | Hot Stocks05:20 EDT Jazz Pharmaceuticals submits MAA to EMA for solriamfetol - Jazz Pharmaceuticals announced the submission of a Marketing Authorization Application to the European Medicines Agency for solriamfetol, a selective dopamine and norepinephrine reuptake inhibitor, as a treatment to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy or obstructive sleep apnea.
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ASX | Hot Stocks05:19 EDT ASE Technology reports Oct. revenue down 0.5% to $1.27B vs. $1.28B in Sept. - Reports October IC-ATM revenue up 2.6% to $728M vs. $709M in September.
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DBVT | Hot Stocks05:19 EDT DBV Technologies to present additional analyses from Viaskin Peanut trial - DBV Technologies announced that additional analyses from clinical trials of Viaskin Peanut will be presented at the 2018 American College of Allergy, Asthma, and Immunology in Seattle, Washington, November 15-19. "Increased Reactivity Threshold in Peanut-allergic Subjects Treated With 12 Months of Epicutaneous Viaskin Peanut"will be presented by Dr. Carla M. Davis, Texas Children's Hospital and Baylor College of Medicine, Houston, TX. "Quantitative Risk Reduction Through Epicutaneous Immunotherapy (EPIT): Results from the PEPITES Phase III Trial"will be presented by Dr. Benjamin Remington, TNO Ziest, The Netherlands. "Serum Biomarkers of Immunomodulation During Peanut Epicutaneous Immunotherapy (EPIT) in Peanut-allergic Subjects"will be presented by Dr. Matthew Greenhawt, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO.
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