Stockwinners Market Radar for August 20, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
PLM | Hot Stocks18:49 EDT PolyMet Mining reports court declined to hear petition for environmental review - Poly Met Mining inc., a wholly-owned subsidiary of PolyMet Mining Corp. reports the Minnesota State Supreme Court declined to hear a petition for review by environmental groups to a lower court decision regarding the environmental review for the NorthMet copper-nickel-precious metals project. Two environmental groups had petitioned the court for review of a unanimous May 28, 2019 Court of Appeals decision that upheld the scope of the environmental review prepared for the NorthMet Project by the Minnesota Department of Natural Resources and rejected the groups' request for the agency to prepare a supplemental Environmental Impact Statement. The Court of Appeals ruling covered three consolidated appeals filed in 2018. The Final Environmental Impact Statement for PolyMet's NorthMet Project was published in November 2015 by the co-lead agencies: the Minnesota Department of Natural Resources, U.S. Forest Service and U.S. Army Corps of Engineers.
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AAL | Hot Stocks18:24 EDT American Airlines to pay $22.1M to settle DOJ false claims act allegations - The U.S. Justice Department announced that American Airlines has agreed to pay approximately $22.1M to resolve its alleged liability under the False Claims Act for falsely reporting the times it transferred possession of United States mail to foreign postal administrations or other intended recipients under contracts with the United States Postal Service. American Airlines is an international airline headquartered in Fort Worth, Texas. USPS contracted with American Airlines to take possession of receptacles of United States mail at six locations in the United States or at various Department of Defense and State Department locations abroad, and then deliver that mail to numerous international and domestic destinations. To obtain payment under the contracts, American Airlines was required to submit electronic scans of the mail receptacles to USPS reporting the time the mail was delivered at the specified destinations. The contracts specified penalties for mail that was delivered late or to the wrong location. Today's settlement resolves allegations that scans submitted by American Airlines falsely reported the time it transferred possession of the mail.
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LZB... | Hot Stocks18:17 EDT Fly Intel: After Hours Movers - UP AFTER EARNINGS: La-Z-Boy (LZB), up 2.8%... Urban Outfitters (URBN), up 1.4%. ALSO HIGHER: SemiLEDs (LEDS), up 15.9% after receiving an offer from a Chinese investor seeking to acquires 680,000 shares of the company's common stock at $3 per share... New Residential Investment (NRZ), up 2.2% after announcing a $200M share repurchase program. DOWN AFTER EARNINGS: Nordson (NDSN), down 6.3%... Cree (CREE), down 4.1%... Scansource (SCSC), down 0.9%... Jack Henry (JKHY), down 0.9%. ALSO LOWER: Tesla (TSLA), down 1.4% after Bloomberg reported that Walmart (WMT) is suing the car maker's energy operations over solar panel fires.
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LEDS | Hot Stocks18:06 EDT SemiLEDs receives offer from Chinese investor to acquire 680K shares - On August 17, 2019, SemiLEDs Corporation received an offer dated August 17, 2019 from Xian Chang Ma, an individual investor resident in China, to purchase 680,000 shares of the company's common stock at $3.00 per share, according to a regulatory filing. This would represent approximately 19% of the currently outstanding shares of the company, or 16% after the closing. The sale of the shares is subject to the Board accepting the offer and the negotiation and execution of a definitive stock purchase agreement. Upon the closing of the sale, the Board of Directors expects to nominate Ma to the company's Board of Directors. Ma is the Chairman and CEO of Shandong Tengjunxiang Biotechnology Co., Ltd. The offer also contemplates that the company would change the Chinese name of its principal subsidiary from SemiLEDs Optoelectronics Co., Ltd. to SemiLEDs Tengjun Technology Co., Ltd. The company's Board will decide whether to pursue the offer on or before 5:00PM EST August 30th, 2019. There is no assurance that the Board of Directors will approve the investment, if at all. Even if the offer is accepted, the company might not be able to negotiate and enter into a definitive stock purchase agreement on acceptable terms or that any sale will be completed. The company has previously announced similar investments that were not completed. Therefore, you should not rely on the possibility that the investment will be completed, if at all, when deciding whether to purchase or sell the company's common stock.
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CE | Hot Stocks18:01 EDT Celanese announces ethyl acetate price increase in Europe - Celanese Corporation announced it will increase list and off-list selling prices for ethyl acetate to EUR100 per MT. The price increase is for orders shipped and will be effective immediately, or as contracts otherwise allow, and is incremental to any previously announced increases.
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WMT | Hot Stocks17:50 EDT Walmart's Furner sells nearly 8,000 common shares - In a regulatory filing, Walmart executive VP John R. Furner disclosed the sale of 7,900 common shares of the company at a price of $114.7197 per share.
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BA | Hot Stocks17:41 EDT Boeing awarded $154.89M Army contract modification to procure Apache helicopters - Boeing was awarded a $154.89M modification to a contract to procure new-build Apache AH 64E helicopters. Work will be performed in Mesa, Arizona, with an estimated completion date of December 31, 2022. FY18 and FY19 aircraft procurement, Army funds in the amount of $154.89M were obligated at the time of the award. U.S. Army Contracting Command is the contracting activity.
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CGC | Hot Stocks17:35 EDT GTEC provides update on acquisition of Canopy Growth cultivation facility - GTEC Holdings provided an update to its plans to acquire a cultivation facility located in Kelowna, British Columbia. On July 22, 2019 GTEC issued a news release regarding its plans to acquire a Kelowna cultivation facility from Canopy Growth Corporation. This facility is purpose-built to produce premium cannabis, near completion, and will have estimated annual output of 4,000 KG when complete. GTEC and Canopy Growth have entered into an Amending Agreement that extends the Purchaser's Condition Waiver Date to September 16, 2019. This extension provides GTEC with additional time to pursue satisfactory financing options in order to complete the transaction. GTEC would also like to confirm that based on current market conditions, it does not intend to finance this acquisition by issuing equity or convertible equity/debt instruments at an issuance price less than its most recent financing which closed on March 21, 2019. The company is currently exploring alternative financing options, including commercial debt and/or divesting of certain non-core non-operational assets. If the company is unable to obtain financing that is satisfactory to its Board of Directors; then it will not proceed with the transaction and be entitled to a full refund of its $250,000 deposit, without any further liabilities, penalties or obligations.
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WTRH | Hot Stocks17:34 EDT Waitr Holdings jumps almost 9% after director Tilman Fertitta buys 1M shares - Shares of Waitr Holdings are up 12c or 8.70% to $1.50 per share in after-hours trading after Tilman Fertitta disclosed that he purchased 1,000,000 shares of the stock.
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WTRH | Hot Stocks17:28 EDT Waitr Holdings director Tilman Fertitta buys 1M shares of company stock - Waitr Holdings director Tilman Fertitta disclosed in a filing that he had purchased 1,000,000 shares of company stock at an average price of $$1.43 per share Between August 16 and August 20.The total transaction value of the purchase was $1,426,000.
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HTBK | Hot Stocks16:54 EDT Heritage Commerce receives regulatory approval for merger - Heritage Commerce, the holding company for Heritage Bank of Commerce, announced that it had received the required regulatory approvals from the Federal Reserve and the State of California Department of Business Oversight relating to the previously announced Agreement and Plan of Merger and Reorganization where by Presidio Bank will merge with and into Heritage Bank of Commerce in an all-stock transaction. The transaction is expected to close in the Q4, subject to approval by both Heritage shareholders and Presidio Bank shareholders at meetings to be held on August 27 and satisfaction of customary closing conditions. Upon completion of the transaction, the combined company will have approximately $4.0B in assets and 17 branches in the Greater San Francisco Bay Area, after branch consolidation.
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AIG | Hot Stocks16:44 EDT AIG names Sabra Purtill as Deputy CFO, Head of Treasury - American International Group announced that Sabra Purtill will join the company in a newly established role as Deputy CFO, Head of Treasury, Investor & Rating Agency Relations, and Corporate Development, effective August 28. Ms. Purtill will be based in New York and report to Mark Lyons, AIG's Executive Vice President and CFO.
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AMCR | Hot Stocks16:41 EDT Amcor declares quarterly dividend of 12c per share - The Amcor Board of Directors declared a June quarterly cash dividend of 12c cents per share. Combined with dividends previously declared and paid in relation to the 2019 fiscal year, the total 2019 financial year dividend is 45.5c per share. The ex-dividend date will be September 10, the record date will be September 11, and the payment date will be October 8.
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KLAC | Hot Stocks16:41 EDT KLA-Tencor officer Amichai Steimberg sells over $1.2M in company shares - KLA-Tencor officer Amichai Steimberg disclosed in a filing that he had sold 8,962 shares of company stock at an average price of $138.80 per share on August 19. The total transaction value of the sale was $1,243,906.
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AMCR | Hot Stocks16:39 EDT Amcor approves $500M share buyback - Amcor CEO Ron Delia said: "2019 was a transformative year for Amcor, marked by the successful completion of the Bemis acquisition and our listing on the New York Stock Exchange. The integration of Bemis is well underway and we remain confident in our ability to deliver $180 million of pre-tax cost synergies by the end of the 2022 fiscal year. The legacy Amcor business performed well during the 2019 financial year, delivering results right in line with expectations and building momentum in several areas including safety, sales and working capital. Overall, Amcor delivered net income growth of 9% in constant currency terms with good performance in both the Rigid Packaging and Flexibles reporting segments. Our financial profile is strong and will be enhanced as we deliver financial benefits from the Bemis acquisition and continued organic growth across the business. Amcor's capacity to drive shareholder returns is evident in the initiatives announced today including increasing the dividend, returning $500 million to shareholders through a share buy-back and investing at least $50 million in strategic projects to accelerate our sustainability agenda."
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CECO | Hot Stocks16:35 EDT Career Education VP Michele Peppers sells over $221K in company shares - Career Education VP Michele Peppers disclosed in a filing that she had sold 10,000 shares of company stock at an average price of $22.17 per share between August 16 and August 19. The total transaction value of the sale was $221,700.
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NDSN | Hot Stocks16:34 EDT Nordson expects flat to modest organic sales growth in FY19 - Expects an unfavorable foreign currency effects of approximately 2% on sales as compared to the prior year. The company, said, "As we approach the end of our fiscal year, the effect of recent macroeconomic trends has had a more significant impact than most anticipated, particularly on electronics end markets. That said, the strength of our position as a valued solutions provider to our customers combined with the diversity of our end markets gives us confidence that we will continue to drive organic growth going forward."
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NDSN | Hot Stocks16:33 EDT Nordson reports FY19 backlog $431M, up 3% vs. last year
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ORLY | Hot Stocks16:33 EDT O'Reilly Automotive to acquire Mayasa Auto Parts, terms not disclosed - O'Reilly Automotive announced that it has entered into a definitive stock purchase agreement with the shareholders of Mayoreo de Autopartes y Aceites, S.A. de C.V., headquartered in Guadalajara, Jalisco, Mexico, under which O'Reilly will acquire all of the outstanding shares of Mayasa and affiliated entities. The stock purchase is expected to be completed in the fourth quarter of this year, subject to customary closing conditions and regulatory approvals.
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SCSG | Hot Stocks16:28 EDT SouthCrest Financial Group announces $5M share repurchase pact - SouthCrest Financial Group, the holding company for SouthCrest Bank, announced that it has received approval for a program to repurchase up to $5M in shares of SCSG common stock through June 30, 2020. CEO Brian D. Schmitt stated, "We are always looking for the best uses of the Company's capital, and currently we believe that future shareholder value will be enhanced through a buyback today. If SouthCrest's capital allocation opportunities change, we will pivot to our most efficient path at that time."
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ABBV | Hot Stocks16:23 EDT AbbVie VP Jeffrey Stewart buys over $1M in company shares - AbbVie VP Jeffrey Stewart disclosed in a filing that he had purchased 15,552 shares of company stock at an average price of $64.44 per share on August 16. The total transaction value of the purchase was $1,002,169.
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CREE | Hot Stocks16:20 EDT Cree down 7.5% after Q4 results, downbeat Q1 guidance
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LZB | Hot Stocks16:19 EDT La-Z-Boy CEO says 'home furnishings environment remains somewhat challenging' - CEO Darrow concluded, "The home furnishings environment remains somewhat challenging amid tariff uncertainty and other geopolitical concerns. Against that backdrop, however, we continue to believe La-Z-Boy is competitively well positioned with a strong brand; multi-channel distribution, including a growing retail business; and a world-class supply chain, which we continue to work to optimize. Additionally, we are optimistic about the long-term growth prospects for Joybird as our eCommerce strategy and business continue to evolve. Our balance sheet remains healthy and we are making prudent investments to deliver long-term performance for all stakeholders."
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LZB | Hot Stocks16:18 EDT La-Z-Boy reports Q1 adjusted operating margin 6.3% vs. 6.1% a year ago
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LZB | Hot Stocks16:18 EDT La-Z-Boy reports Q1 SSS for company-owned Retail segment up 3.5% - In Q1: Written same-store sales for the La-Z-Boy Furniture Galleries network increased 4.7%. Delivered same-store sales for company-owned Retail segment increased 3.5%
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NRZ | Hot Stocks16:17 EDT New Residential announces $200M share repurchase program - New Residential Investment announced that the company's Board of Directors authorized the repurchase of up to $200M of the company's common shares through December 31, 2020.
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SEDG | Hot Stocks16:16 EDT SolarEdge appoints Uri Bechor as COO - SolarEdge Technologies announced the appointment of Uri Bechor as COO. Bechor brings to SolarEdge over twenty years of experience serving in both senior vice president and GM level roles at Flextronics International. In his last position, Bechor served as Senior Vice President, Global Operations, Europe and the Americas where he oversaw more than forty manufacturing sites and was responsible for revenues of more than $10B.
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PLXS | Hot Stocks16:15 EDT Plexus announces $50M share repurchase program - Plexus announced that its board of directors has approved a new share repurchase program under which the company is authorized to repurchase up to $50M of its common stock beginning upon expiration of the company's previous share repurchase program. This most recent authorization is expected to extend through fiscal 2020.
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LL | Hot Stocks16:13 EDT Lumber Liquidators founder Sullivan discloses 5.96% stake - In a regulatory filing, Thomas Sullivan disclosed a 5.96% stake. The filing stated: "The source of funding for the transactions pursuant to which the reporting persons obtained beneficial ownership of common stock was derived from the personal capital of Thomas D. Sullivan. Within the last 60 days, all shares of common stock acquired were bought on the open market...[Sullivan] acquired the stock in the belief that the shares are undervalued. [He is] considering all their options and, while they have no present plan to do so, reserves the right and are considering whether to...(i) acquire additional shares and/or other equity, debt, notes, instruments or other securities of the issuer and/or its affiliates (collectively, securities) in the open market or otherwise; (ii) dispose of any or all of their Securities in the open market or otherwise; or (iii) engage in any hedging or similar transactions with respect to the securities."
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URBN | Hot Stocks16:09 EDT Urban Outfitters down 7.9% after reporting Q2 earnings results
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URBN | Hot Stocks16:09 EDT Urban Outfitters says total inventory increased by $64.4M as of July 31 - As of July 31, total inventory increased by $64.4M, or 17.2%, on a year-over-year basis. Comparable retail segment inventory increased 5% at cost. The remainder of the increase was primarily related to an increase in inventory in transit.
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URBN | Hot Stocks16:08 EDT Urban Outfitters reports Q2 comparable retail segment net sales down 3% - Q2 comparable retail segment net sales decreased 3%, driven by negative retail store sales, partially offset by growth in the digital channel. By brand, comparable retail segment net sales increased 6% at Free People and decreased 3% at the Anthropologie Group and 5% at Urban Outfitters. Wholesale segment net sales decreased 8%.
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MOGO | Hot Stocks16:03 EDT Mogo Finance surpasses 900,000 member milestone - Mogo announced it has surpassed the 900,000 member milestone as it continues to establish itself as an increasingly important part of millennials' financial lives. The company commented: "Importantly, this growth is being led by the desirable millennial segment, which represents 65% of our new member additions." And added: "We continue to see opportunities to increase our average revenue per member of more than $70 today, including the expected impact of new fee-based lending revenue from our partner lending platform and the upcoming Mogo Platinum Prepaid Visa Card roll-out."
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VTGN | Hot Stocks15:26 EDT VistaGen not 'a one product' company, says CEO - VistaGen Therapeutics (VTGN) is a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system diseases and disorders with high unmet need, including major depressive disorder, neuropathic pain, social anxiety disorder and suicidal ideation. In an exclusive interview with The Fly, the company's CEO Shawn Singh clarified possible misconceptions about VistaGen and its pipeline: "A key misconception is that we are a one-product, one-disease company. Nothing could be further from the truth. We have three novel, differentiated, patent-protected, clinical-stage product candidates, each of which, as is often the case with the evolution of CNS products, has therapeutic and thus commercial potential for treatment of multiple diseases and disorders in multiple markets where current treatments are inadequate at meeting the needs of millions of patients. We have several products and opportunities to explore many markets with each of them." "Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company.
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VTGN | Hot Stocks15:11 EDT VistaGen's Singh says partnerships in large markets outside U.S. make most sense - VistaGen Therapeutics (VTGN) is a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system diseases and disorders with high unmet need. In an exclusive interview with The Fly, the company's CEO Shawn Singh discussed potential partnerships: "We are always open to collaborative relationships that enhance our potential to achieve optimal commercial benefits from our product candidates and thereby deliver extraordinary value to patients and our shareholders. In certain large and growing markets outside North America, such as China and Japan, and possibly the EU and Korea, partnering for Phase 3 development, and possibly some Phase 2 development, as well as commercialization of one or more of our product candidates may make the most sense strategically. We have been and certainly will continue exploring possibilities and interest from potential partners in parallel with our ongoing and planned clinical development activities in the U.S." "Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company. The remainder of this interview to follow.
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SABR | Hot Stocks15:10 EDT Sabre to challenge DOJ lawsuit seeking to block Farelogix acquisition - Sabre Corporation announced that it will challenge the lawsuit filed by the U.S. Department of Justice seeking to block the company's planned acquisition of Farelogix, Inc. Farelogix, a recognized innovator in the highly competitive airline technology space whose New Distribution Capability technology is used by a number of airlines around the world, will bring capabilities to Sabre that will accelerate the delivery of the industry's first end-to-end NDC-enabled solution for the retailing, distribution and fulfillment of travel, the company said. Sabre is confident of the pro-competitive nature of this transaction, that it will succeed in court, and that the transaction will ultimately be completed. Sabre contended that the DOJ's claims "lack a basis in reality and reflect a fundamental misunderstanding of the industry," adding that the department "claims that Sabre and Farelogix compete head to head for airline bookings in the United States, but that claim misstates Farelogix's role in the industry." Sabre and Farelogix have extended the termination date of their acquisition agreement to April 30, 2020, allowing time to resolve the challenge by the DOJ. Sabre will file its formal written response to the DOJ's complaint in court at the appropriate time.
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CLVS | Hot Stocks14:47 EDT Elk Creek Partners reports 5.25% passive stake in Clovis - In a regulatory filing, Elk Creek Partners disclosed a 5.25% stake in Clovis, which represents about 2.9M shares. The filing does not allow for activism.
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VTGN | Hot Stocks14:45 EDT VistaGen CEO says preparing for 200-patient Phase 2b study of PH10 in MDD - VistaGen Therapeutics (VTGN) is a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system diseases and disorders with high unmet need. In an exclusive interview with The Fly, the company's CEO Shawn Singh talked about VistaGen's PH10 and PH94B studies: "We have two novel, first-in-class neuroactive nasal spray product candidates, each, like AV-101, with an exceptional safety profile in studies to date and each with therapeutic potential in multiple large and growing mental health markets where current treatments are inadequate at meeting the needs of millions of patients. PH10 is a neurosteroid with a differentiated mechanism of action. We are currently preparing for a 200-patient Phase 2b study of PH10 as a standalone treatment for MDD. PH10 demonstrated rapid-onset antidepressant effects at microgram doses in Phase 2a, and we will look to expand our Phase 2 evaluation of PH10 in 2020, ideally beginning near the end of 2020, following ongoing work on our go-to-market formulation for use in Phase 2b and Phase 3. Similarly, but a distinct NCE, PH94B is a novel neuroactive nasal spray with rapid-onset therapeutic effects - within 10-15 minutes - for treatment of social anxiety disorder, or SAD, at microgram doses, without systemic exposure. We are advancing work on our go to market formulation of PH94B for use in pivotal Phase 3 studies, as well as finalizing regulatory activities to support a study launch in mid-2020, the first of what is anticipated to be two 200-patient Phase 3 studies, as well as standard long-term safety studies. The SAD market is large, about 20M in the U.S., and without adequate therapies for most, with an unfortunate off-label use of potentially addictive benzodiazepines at epidemic levels. We are excited about PH94B's potential to be the first fast-acting FDA-approved treatment for SAD. With depression and anxiety at highly prevalent and growing levels, new safe, effective, fast-acting treatment alternatives are critically needed, and we are excited about the potential of AV-101, PH94B and PH10 to address the large and growing unmet needs." "Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company. The remainder of this interview to follow.
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VTGN | Hot Stocks14:31 EDT VistaGen CEO expects preliminary results for suicidal ideation trial by year-end - VistaGen Therapeutics (VTGN) is a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system diseases and disorders with high unmet need. In an exclusive interview with The Fly, the company's CEO Shawn Singh discussed VistaGen's additional AV-101 trials: "The VA is sponsoring, and Baylor University is conducting, a Phase 1b study in healthy military veterans that we all hope will be the first-step supporting Phase 2a clinical development of AV-101 for treatment of suicidal ideation late next year. The Baylor/VA study is ongoing and we might potentially have preliminary results by year end. We are in the planning stages for Phase 2a clinical development of AV-101 beginning in late-2020 for (a) treatment of depression following successful ketamine therapy (to maintain the benefits of ketamine therapy on an at-home outpatient basis, rather than the in-clinic administration required by ketamine therapy, and without ketamine's psychological side effects or its safety concerns), (b) as an oral, non-opioid treatment for neuropathic pain, and (c) as an oral treatment for levodopa-induced dyskinesia (LID) experienced by Parkinson's disease patients, that maintains the benefits of levodopa for Parkinson's and without causing the side effects of current amantadine therapy for LID." "Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company. The remainder of this interview to follow.
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VTGN | Hot Stocks14:17 EDT VistaGen CEO sees ELEVATE topline results before year-end - VistaGen Therapeutics (VTGN) is a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system diseases and disorders with high unmet need, including major depressive disorder, neuropathic pain, social anxiety disorder and suicidal ideation. In an exclusive interview with The Fly, the company's CEO Shawn Singh talked about its ongoing ELEVATE trial, a Phase 2 study of AV-101 as an adjunctive treatment of major depressive disorder in patients with an inadequate response to antidepressants: "We are very excited about our progress in ELEVATE, our potentially transformative Phase 2 study of AV-101 as an add-on treatment - together with an FDA-approved oral antidepressant - for adults with major depressive disorder, MDD. We have already achieved our targeted enrollment, which is always a key milestone in a clinical study, and we are on track to deliver topline results of the study before calendar year-end, as planned." "Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company. The remainder of this interview to follow.
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SABR | Hot Stocks14:05 EDT DOJ sues to block Sabre's acquisition of Farelogix - The U.S. Department of Justice filed a civil antitrust lawsuit seeking to block Sabre Corporation's $360M acquisition of Farelogix, Inc. The Department said that Sabre and Farelogix compete head-to-head to provide booking services to airlines. Booking services are IT solutions that allow airlines to sell tickets and ancillary products through traditional brick-and-mortar and online travel agencies to the traveling public. The Department said that the acquisition would eliminate competition that has substantially benefitted airlines and consumers. The Antitrust Division's lawsuit alleges that the transaction would allow Sabre, the largest booking services provider in the United States, to eliminate a disruptive competitor that has introduced new technology to the travel industry and is poised to grow significantly. Reference Link
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VTGN | Hot Stocks14:00 EDT VistaGen not 'a one-product, one-disease company,' Singh says
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VTGN | Hot Stocks14:00 EDT Partnerships in large markets outside U.S. make most sense, VistaGen CEO says
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VTGN | Hot Stocks14:00 EDT VistaGen preparing for 200-patient Phase 2b study of PH10 in MDD, CEO says
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VTGN | Hot Stocks14:00 EDT VistaGen sees preliminary AV-101 study results in suicidal ideation by year-end
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VTGN | Hot Stocks14:00 EDT VistaGen CEO says on track to deliver ELEVATE topline results before year-end
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PTE | Hot Stocks12:57 EDT PolarityTE granted Canadian patent related to micro-aggregate technology - PolarityTE announced that the Canadian Intellectual Property Office has granted Patent No. 2 969 707 entitled "Methods for Development and Use of Minimally Polarized Function Cell Micro-Aggregate Units in Tissue Applications Using LGR4, LGR5, And LGR6 Expressing Epithelial Stem Cells." This patent relates to PolarityTE's unique micro-aggregate technology capable of assembling functional polarized tissue, as well as methods for producing compositions including these micro-aggregates, and the use of these micro-aggregates for therapeutic treatment of skin, skin repair and skin restoration. Aspects of this micro-aggregate technology are central to the company's SkinTE product, which is commercially available in the United States for the repair, replacement, reconstruction or supplementation of skin tissue.
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CFBI | Hot Stocks12:54 EDT Community First to acquire ABB Financial for $7.50 per share - Community First Bancshares, the parent company of Newton Federal Bank, and ABB Financial Group, parent company of Affinity Bank, announced that they have entered into a definitive merger agreement whereby CFBI has agreed to acquire ABB and its wholly owned bank subsidiary, Affinity Bank, in an all-cash transaction. The transaction has been unanimously approved by the Boards of Directors of each company and is expected to close in the fourth quarter of 2019 or the first quarter of 2020. Under the terms of the merger agreement, ABB shareholders will receive cash merger consideration of $7.50 for each share of ABB. Including consideration received by ABB option holders, the transaction is valued at approximately $40.3M. Additionally, ABB's preferred stock and trust preferred securities will be redeemed at the close of the transaction, and all accrued but unpaid dividends and interest will be paid on the preferred stock and trust preferred securities. The transaction is expected to be meaningfully accretive to CFBI's 2020 earnings per share, excluding one-time merger costs, and the tangible book value earn-back is expected to be less than 3.5 years, utilizing the crossover method. Upon completion of the transaction, Ed Cooney will become CEO of CFBI and Newton Federal Bank and will also become a director of both entities. Johnny Smith of CFBI will remain President of CFBI and Newton Federal Bank and will continue to serve on the boards of both entities. Affinity Bank will merge into Newton Federal Bank. Based on June 30, 2019 bank-level financials, and excluding merger accounting adjustments, the combined institution will have approximately $613M in assets, $465M in deposits and $500M in loans. Completion of the transaction is subject to customary closing conditions, including the receipt of required regulatory approvals and the approval of ABB's shareholders.
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BHGE | Hot Stocks12:04 EDT Baker Hughes awarded contract, granted notice to proceed by Venture Global LNG - Baker Hughes (BHGE) announced that it has been awarded a contract and granted notice to proceed on the construction of its comprehensive LNG technology solution for Venture Global LNG's Calcasieu Pass project. The final notice to proceed, or FNTP, follows Venture Global's Final Investment Decision and Financial Close for Calcasieu Pass and is part of the companies' previously-announced supply agreement. The agreement includes BHGE's highly-efficient and reliable modular liquefaction trains, and power generation and electrical distribution equipment for the Calcasieu Pass Project. Under the contract, BHGE will provide an LNG liquefaction train system, or LTS, with 18 modularized compression trains across nine "blocks," for a total nameplate capacity of 10M tonnes per annum, or MTPA. The modularized system offers a "plug and play" approach that enables faster installation and lower construction and operational costs. These modules will be manufactured, assembled, tested and transported from BHGE's state-of-the-art plants in Italy. Additionally, BHGE will leverage advanced technologies from across its portfolio to deliver a comprehensive power island system, or PIS, that includes power generation and electrical distribution equipment for the facility. Equipment deliveries are expected to begin in the second half of 2020. BHGE will also provide associated field support services to assist in the oversight, installation and commissioning of the supplied equipment. These are the first contracts awarded under the master equipment supply agreement between Venture Global LNG and BHGE for 60 MTPA of production capacity.
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MSG | Hot Stocks12:00 EDT Madison Square Garden falls -9.0% - Madison Square Garden is down -9.0%, or -$26.43 to $267.00.
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SE | Hot Stocks12:00 EDT Sea Limited falls -9.9% - Sea Limited is down -9.9%, or -$3.56 to $32.54.
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FN | Hot Stocks12:00 EDT Fabrinet falls -15.7% - Fabrinet is down -15.7%, or -$8.89 to $47.57.
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TCI | Hot Stocks12:00 EDT Transcontinental Realty Inc rises 10.7% - Transcontinental Realty Inc is up 10.7%, or $2.52 to $26.07.
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AVYA | Hot Stocks12:00 EDT Avaya rises 11.4% - Avaya is up 11.4%, or $1.42 to $13.85.
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CMCM | Hot Stocks12:00 EDT Cheetah Mobile rises 33.6% - Cheetah Mobile is up 33.6%, or $1.11 to $4.41.
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MA... | Hot Stocks11:34 EDT Apple launches Apple Card for U.S. customers - Apple Card, a credit card created by Apple (AAPL), is available in the U.S. Customers can apply for Apple Card through the Wallet app on iPhone and start using it right away with Apple Pay in stores, in apps and on websites. Apple Card has no fees, encourages customers to pay less interest, offers a view of spending and provides privacy and security. Apple Card's rewards program, Daily Cash, gives back a percentage of every purchase as cash on customers' Apple Cash card each day. Customers will receive 2 percent Daily Cash every time they use Apple Card with Apple Pay, and 3 percent Daily Cash on all purchases made directly with Apple, including at Apple Stores, apple.com, the App Store, the iTunes Store and for Apple services. Apple Card is extending 3 percent Daily Cash to more merchants and apps. Customers will receive 3 percent Daily Cash when they use Apple Card with Apple Pay for Uber (UBER) and Uber Eats. Customers can request a ride through Uber in more than 700 cities across the globe and order a meal through Uber Eats in more than 500 cities around the world. Apple Card will continue to add more popular merchants and apps in the coming months. Apple is partnering with Goldman Sachs (GS) as its issuing bank. Goldman Sachs will never share or sell data to third parties for marketing and advertising. Apple is also partnering with Mastercard (MA) to provide the support of a global payments network. Apple Card is now available to qualified customers in the US with iPhone 6 and later. Reference Link
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TRMD | Hot Stocks11:17 EDT TORM PLC (Class A Stock) trading resumes
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TJX | Hot Stocks11:16 EDT TJX sees buying back approximately $1.75B of TJX stock for FY20 - Comments taken from Q2 earnings conference call.
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VUZI | Hot Stocks11:15 EDT Vuzix receives follow-on Smart Glasses order from 1Minuut Innovation - Vuzix Corporation announced the company has received a follow-on Smart Glasses order from 1Minuut Innovation totaling over 100 M-series systems with plans to upgrade and to upgrade and transition to the M400 very shortly. 1Minuut's main focus is delivering secured video-streaming and recording through their Genzo mobile software platform. Genzo facilitates a mobile communications platform to chat or video call using Vuzix Smart Glasses.
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TJX | Hot Stocks11:14 EDT TJX saw small impact due to tariffs, management monitoring developments closely
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TJX | Hot Stocks11:13 EDT TJX CEO says feels 'very comfortable' with inventory levels
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TJX | Hot Stocks11:12 EDT TJX sees Marshall's ecommerce launch in 2H19
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TRMD | Hot Stocks11:12 EDT TORM PLC (Class A Stock) trading halted, volatility trading pause
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FB | Hot Stocks11:08 EDT Facebook announces new tool for users' data control - Facebook announced its introduction of "Off-Facebook Activity," which it calls a "new tool that gives you more control of your data." In the page describing the tool, Facebook stated: "Much of what you do online generates data-like when you're searching for vacation spots or buying a backpack. Occasionally, businesses share that data with Facebook...One way that data can be used is to help businesses find the right audience to show ads for things you might like-such as a deal on backpacks. These ads are what make most of the internet available free of charge, including Facebook...Now you can see a summary of information Facebook receives about your activity on other apps and websites. You also have the option to disconnect it from your account." Reference Link
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TJX | Hot Stocks11:08 EDT TJX sees buying back approximately $1.75B of TJX stock for FY19 - Comments taken from Q2 earnings conference call.
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AVYA | Hot Stocks10:40 EDT Avaya up 9% after receiving buyout offer
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TXMD | Hot Stocks10:14 EDT SEC charges TherapeuticsMD with Regulation FD violations - The Securities and Exchange Commission charged TherapeuticsMD with violations of Regulation FD based on its sharing of material, nonpublic information with sell-side research analysts without also disclosing the same information to the public, the SEC announced. The SEC's order finds that on two separate occasions in 2017, TherapeuticsMD selectively shared material information with analysts about the company's interactions with the U.S. Food and Drug Administration. As detailed in the SEC's order, on June 15, 2017, one day after a publicly-announced meeting with the FDA about a new drug approval, TherapeuticsMD sent private messages to sell-side analysts describing the meeting as "very positive and productive." TherapeuticsMD's stock price closed up 19.4% on heavy trading volume the next day. At that time, the company had not issued a press release or made any other market-wide disclosure about the meeting. Then, early in the morning of July 17, 2017, TherapeuticsMD issued a press release announcing that it had submitted additional information to the FDA, but did not yet have a clear path forward regarding its New Drug Application. TherapeuticsMD's stock price declined approximately 16% in pre-market trading following the issuance of the press release. The SEC's order finds that in a call and email to sell-side analysts after the press release was issued but before the market opened, the company selectively shared previously undisclosed details about the June FDA meeting and the information it had subsequently submitted to the FDA. According to the SEC's order, all of the analysts published research notes containing these details, and the stock rebounded to close down only 6.6% for the day. The SEC's order found that at the time of these selective disclosures, TherapeuticsMD did not have policies or procedures regarding compliance with Regulation FD. TherapeuticsMD consented to the SEC's order without admitting or denying the findings and was ordered to cease and desist from future violations of Regulation FD. The company agreed to pay a $200,000 penalty.
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BAESY | Hot Stocks10:06 EDT Indonesian Navy selects BAE Systems' 57mm gun systems for fast attack craft - The Indonesian Navy has selected BAE Systems' Bofors 57 Mk3 naval gun system for the country's KCR-60 fast-attack vessel program. The initial contracts with government-owned shipbuilder PT PAL Indonesia include four 57 Mk3 gun systems. The Bofors 57mm naval gun is designed to address surface, air, and land threats in the littoral environment, and is already in service with a wide range of navies and coast guards, including those of the United States, Canada, Sweden, Finland and Mexico. Three KCR-60 vessels are currently in service with the Indonesian Navy, Tentara Nasional Indonesia-Angkatan Laut, or TNI-AL, with a fourth ship scheduled to be operational in 2021. Two of the new 57 Mk3 systems will be for two KCR-60 vessels currently under construction, while the remaining two guns will be integrated onto two existing KCR-60 ships. The gun systems will be produced at BAE Systems facilities in Karlskoga, Sweden. The first unit is scheduled for delivery in 2020 and the final unit in 2021.
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HD | Hot Stocks10:03 EDT Home Depot says expects 2H19 margins to be better than 1H19 - Says: Has not seen impacts of tariffs flow to consumers yet... Expecting positive comps for Canada for FY... Expects to benefit from lumber prices in 2H19.
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MSG | Hot Stocks10:00 EDT Madison Square Garden falls -8.1% - Madison Square Garden is down -8.1%, or -$23.77 to $269.66.
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SE | Hot Stocks10:00 EDT Sea Limited falls -10.5% - Sea Limited is down -10.5%, or -$3.79 to $32.31.
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FN | Hot Stocks10:00 EDT Fabrinet falls -14.2% - Fabrinet is down -14.2%, or -$8.01 to $48.45.
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HGV | Hot Stocks10:00 EDT Hilton Grand Vacations rises 10.8% - Hilton Grand Vacations is up 10.8%, or $3.04 to $31.25.
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MNK | Hot Stocks10:00 EDT Mallinckrodt rises 12.7% - Mallinckrodt is up 12.7%, or 58c to $5.16.
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SDRL | Hot Stocks10:00 EDT Seadrill rises 18.8% - Seadrill is up 18.8%, or 51c to $3.22.
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CX | Hot Stocks09:49 EDT Cemex commences stock repurchase program - In a regulatory filing earlier, Cemex announced that it has commenced its stock repurchase program, which was approved at the annual general ordinary shareholders' meeting held on March 28. The program approved by the meeting allows Cemex to repurchase up to $500M, or its equivalent in Mexican pesos, of Cemex's shares, or securities representing such shares, until Cemex's general ordinary shareholders' meeting to be held in 2020. On August 19, Cemex repurchased 39M Cemex CPOs, at a weighted-average price of MXN5.899300 per CPO, the filing noted.
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PPDF | Hot Stocks09:47 EDT PPDAI Group falls -10.0% - PPDAI Group is down -10.0%, or -37c to $3.32.
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SE | Hot Stocks09:47 EDT Sea Limited falls -10.3% - Sea Limited is down -10.3%, or -$3.71 to $32.39.
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FN | Hot Stocks09:47 EDT Fabrinet falls -15.3% - Fabrinet is down -15.3%, or -$8.66 to $47.80.
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MNK | Hot Stocks09:47 EDT Mallinckrodt rises 7.2% - Mallinckrodt is up 7.2%, or 33c to $4.91.
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HGV | Hot Stocks09:47 EDT Hilton Grand Vacations rises 9.9% - Hilton Grand Vacations is up 9.9%, or $2.79 to $31.00.
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SDRL | Hot Stocks09:47 EDT Seadrill rises 15.0% - Seadrill is up 15.0%, or 41c to $3.12.
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SNE | Hot Stocks09:38 EDT Sony agrees to acquire video-game developer Insomniac Games - Sony will buy Insomniac Games, the studio behind last year's Marvel's Spider-Man, for an undisclosed price. Insomniac will join the Worldwide Studios family at Sony Interactive Entertainment, Insomniac CEO Ted Price said in a blog post. "We've collaborated with Sony for more than 20 years - spanning all four PlayStation consoles, 20 total games and six franchises. We still work closely today with many of the same Sony teammates as we did when we released the original Spyro the Dragon in 1998. The decision to join forces with Sony extends far beyond familiarity. Our studio vision is to create experiences that have a positive and lasting impact on people's lives. As we look ahead to our future, we know that joining the WWS family gives us the best opportunities to fully achieve that vision on a much larger scale. Further, we believe that Sony shares a similar vision to positively impact players' lives, their employees' lives and the games industry at large." Reference Link
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IAC | Hot Stocks09:33 EDT NurseFly announces acquisition by IAC; terms not disclosed - NurseFly, a marketplace targeting the $17B temporary healthcare staffing industry, announced its acquisition by IAC. NurseFly will join IAC's Emerging & Other segment which also houses the on-demand staffing platform Bluecrew. Terms of the deal were not disclosed. NurseFly will continue to be led by Parth Bhakta, co-founder and CEO, and Eric Conner, co-founder and CTO. Adam Roston, a long-time IAC executive who is also CEO of Bluecrew, will assume the role of Chairman of NurseFly.
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ENDP | Hot Stocks09:33 EDT Endo reaches settlement in principle to resolve Track 1 opioid cases - Endo International announced that its subsidiaries Endo Pharmaceutical, Endo Health Solutions, Par Pharmaceutical and Par Pharmaceutical Companies, collectively, the "Endo Entities", have reached a settlement in principle with the County of Cuyahoga, Ohio, the County of Summit, Ohio and certain related persons in connection with the following lawsuits pending in the U.S. District Court for the Northern District of Ohio: The County of Cuyahoga, et al. v. Purdue Pharma, et al., Case No. 17-OP-45004; and The County of Summit, et al. v. Purdue Pharma, et al., Case No. 18-OP-45090. The settlement will be effective only upon the execution of definitive documentation. The Track 1 Cases assert various claims arising from or otherwise relating to the manufacturing, marketing, distribution, supply, sale, prescribing, use and/or abuse of branded and generic opioid medications. Under the settlement in principle, Endo will pay a total sum of $10M and will provide up to $1M of its Vasostrict and Adrenalin products free of charge, all to be allocated by and between the two plaintiff counties in their sole discretion. Further, in the event of a comprehensive resolution of government-related opioid claims, the Company has agreed that the two plaintiff counties will receive the value they would have received under such resolution less the total value of the settlement in principle announced today. The settlement will include no admission of wrongdoing, fault or liability of any kind by the Endo Entities and is based on the avoidance of litigation risk and associated costs.
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KSS | Hot Stocks09:32 EDT Kohl's says its off to good start with back-to-school season - Kohl's (KSS) says progressively improved in Q2. Says traffic increased in Amazon (AMZN) returns program. Says expects gross margin to be down 35-40 basis points on the year. Says expects full-year share repurchases to be at the high end of $400M-$500M. Says active continues to be bright spot. Says children's segment outperformed the company. Says pleased with digital channel. Says mobile continues to drive traffic. Comments taken from Q2 earnings conference call.
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ASGN | Hot Stocks09:24 EDT ASGN segment awarded three-year, $19M Marine Corps contract - ECS, a segment of ASGN , has been awarded a three-year, firm-fixed-price $19M contract to support the Marine Sierra Hotel Aviation Readiness Program, or M-SHARP. Managed by the United States Marine Corps training and education command, or TECOM, aviation standards branch, M-SHARP is a web-based training management program that supports all Marine aviation operational and headquarters units with real-time forecasting, scheduling, execution and reporting to achieve and maintain combat readiness.
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HD | Hot Stocks09:24 EDT Home Depot says sees FY19 effective tax rate approximately 25% - Says: Expects inventory turns to slow slightly vs. last year... Sees FY19 share repurchases of $5B, $2.5B in second half of year... SSS grew 4.7% in July... U.S. consumer remains healthy.
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TRNO | Hot Stocks09:19 EDT Terreno Realty acquires industrial property in Los Angeles for $18.1M - Terreno Realty acquired an industrial property located in Los Angeles, California for a purchase price of approximately $18.1M. The property consists of five industrial buildings containing approximately 53,000 square feet on approximately 1.9 acres adjacent to the Downtown Los Angeles Arts District. The buildings are at 130-134 and 140-148 South Anderson Street, 1319 Mono Street and 135-151 South Utah Street, provide 11 grade-level loading positions and parking for 83 cars. The property is 90% leased to seven tenants, all of which expire within the next three years. The estimated stabilized cap rate of the property is 5.2%.
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HD | Hot Stocks09:15 EDT Home Depot says all U.S. divisions posted positive comps in Q2 - Says: Saw broad-based growth across stores... Says Pro sales outpaced DIY in U.S... Customer service scores have increased significantly vs. last year... Q2 online sales grew 20% y/y... Lowering FY sales guidance to reflect lumber prices, impact of tariffs... Big ticket transactions up 3.7%. Comments taken from Q2 earnings conference call.
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HD... | Hot Stocks09:12 EDT Fly Intel: Pre-market Movers - HIGHER: Hilton Grand Vacations (HGV), up 10% after the New York Post reported Apollo Global (APO) is considering steps to buy the company. Apollo has given the company three options: It could buy Hilton Grand at a premium to its share price, merge the company with rival Diamond Resorts and keep the combined business public, or tender for Hilton Grand shares at a premium to the current Hilton Grand share price, according to the report... Beyond Meat (BYND), up 6% after JPMorgan analyst Ken Goldman upgraded the stock to Overweight from Neutral. UP AFTER EARNINGS: Home Depot (HD), up 2%... Medtronic (MDT), up 5%... Baidu (BIDU), up 9%. DOWN AFTER EARNINGS: Sea Limited (SE), down 12%... Fabrinet (FN), down 17%. ALSO LOWER: Sarepta (SRPT), down 17% after the company announced it had received a complete response letter from the FDA for its new drug application for golodirsen... Elanco (ELAN), down 8% after entering into an agreement with Bayer AG (BAYRY) to acquire its animal health business in a transaction valued at $7.6B... Synlogic (SYBX), down 30% after discontinuing development of SYNB1020, an early stage clinical product candidate for the treatment of hyperammonemia.
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DOMO | Hot Stocks09:11 EDT TaylorMade expands use of Domo to Japanese operations - Domo announced that TaylorMade has expanded its use of Domo from the United States to its entire Japanese operations. This also includes the expansion of the Domo platform across Asia Pacific to build stronger relationships between employees in the region and other global offices, and help drive its business forward.
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QEPC DOOR | Hot Stocks09:08 EDT Q.E.P. Company appoints James Hair to board of directors - Q.E.P. CO. (QEPC) announced the appointment of James Hair to its Board of Directors. Hair is currently the President, Global Residential Business, of Masonite International Corporation (DOOR).
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GIGM | Hot Stocks09:07 EDT GigaMedia's CEO acquires 69,742 shares of the company - GigaMedia announced that its CEO Cheng-Ming Huang a.k.a. James Huang, has purchased a total of 69,742 shares of GigaMedia stock by Pacific Star Universal Group Ltd. at an average price of $2.3523 on August 15th and 19th, 2019. The purchases were made during an open window period and in full compliance with all company and legal guidelines.
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INGR ATR | Hot Stocks09:06 EDT Ingredion appoints AptarGroup CEO Stephen Tanda to board of directors - Ingredion Incorporated (INGR) announced the appointment of Stephan Tanda to its board of directors, effective August 19. Since 2017, Tanda has served as president and CEO of AptarGroup (ATR).
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VISI NTAP | Hot Stocks09:05 EDT Volt Information Sciences names Bob Houghton as CIO - Volt Information Sciences (VISI) announced Bob Houghton will serve as chief information officer, or CIO, based out of the company's headquarters in Orange, California. Houghton joins Volt with over 25 years of experience in information technology, spending the past eight years at NetApp (NTAP), where he most recently served as CIO west. Over his career, Houghton has designed, implemented and operationalized strategies and IT systems for global enterprises.
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TYPE | Hot Stocks09:05 EDT Gilead Capital intends to vote against the sale of Monotype - Gilead Capital, a long-term shareholder of Monotype Imaging Holdings, sent a letter to the Company's Board of Directors expressing its concerns regarding the proposed sale of Monotype to the private equity firm HGGC for $19.85 per share. The letter conveys that the inadequacy of the $19.85 price is evident from: the Board's buyback of minority shares in the same quarter at the same $19.85 price; the bottom-quartile "premium" on a stock price near its six-year low; and the significant recent earnings beat. Gilead Capital believes that the Company is worth at least $30 per share. The Board's lack of transparency with respect to the deal and the Company's second-quarter earnings raises questions about whether it engaged in a rigorous process to secure a fair price for shareholders. Gilead Capital currently intends to vote against the transaction.
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FCEL | Hot Stocks09:04 EDT FuelCell appoints Jason Few as president, CEO - FuelCell Energy announced the appointment of Jason Few as its new President and CEO, effective as of August 26, 2019. Few joined the FuelCell Energy Board of Directors in November 2018. Few, along with the Company's executive leadership team, will be responsible for the revitalization and advancement of FuelCell Energy, including its ongoing restructuring efforts, its efforts to enhance commercial activity, and its efforts to improve operational effectiveness. Few, age 53, previously served as President of Sustayn Analytics, a data visualization and analytics company focused on the waste and recycling industries. Few will continue to serve on the board of FuelCell Energy as a non-independent director. The FuelCell Energy Board is currently evaluating its composition given Mr. Few's appointment, and expects to expand its membership in the coming months. Jennifer Arasimowicz will remain in her role as General Counsel, Corporate Secretary, EVP, and CCO and, along with the Company's EVP, Treasurer, and CFO Michael Bishop, the Company's EVP and COO Michael Lisowski, and the Company's EVP and CTO Anthony Leo, will report directly to Mr. Few. The roles of Chief Restructuring Officer, held by Laura Marcero, and Deputy Chief Restructuring Officer, held by Lee Sweigart, will remain, and, effective as of August 26, 2019, they will report to both the Board of Directors and Mr. Few, as Chief Executive Officer of the Company.
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TYPE | Hot Stocks09:02 EDT Gilead Capital intends to vote against the sale of Monotype - Gilead Capital, a long-term shareholder of Monotype Imaging Holdings, sent a letter to the Company's Board of Directors expressing its concerns regarding the proposed sale of Monotype to the private equity firm HGGC for $19.85 per share. The letter conveys that the inadequacy of the $19.85 price is evident from: the Board's buyback of minority shares in the same quarter at the same $19.85 price; the bottom-quartile "premium" on a stock price near its six-year low; and the significant recent earnings beat. Gilead Capital believes that the Company is worth at least $30 per share. The Board's lack of transparency with respect to the deal and the Company's second-quarter earnings raises questions about whether it engaged in a rigorous process to secure a fair price for shareholders. Gilead Capital currently intends to vote against the transaction.
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HJLI | Hot Stocks08:55 EDT Hancock Jaffe completes two additional VenoValve implantations for study - Hancock Jaffe Laboratories announced that it has implanted VenoValves in two additional patients, as part of HJLI's first-in-man Bogota study. Eight patients have now received VenoValves as part of the initial phase of the first-in-man study. The procedures very went well and there are no early signs of adverse events, the company said in a statement. In July, ninety-day data from the first-in-man study was released which indicated substantial improvements in all end points of the study, including reflux, manifestations of the disease; and pain. The next data from the first-in-man study is expected to be released in late October of 2019, at which point five patients will be more than 6 months post VenoValve surgery, and three patients will be between 2 to 4 months post-surgery. The company believes that the October data will be sufficient to re-engage the FDA, in preparation for filing the Investigational Device Exemption application for the U.S. pivotal trial, which the company expects to file in early 2020. The first-in-human Bogota study for the VenoValve is the precursor to the U.S. pivotal trial, for which the company hopes to receive approval in the second half of 2020.
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KSHB GTBIF | Hot Stocks08:51 EDT KushCo Holdings adds former Green Thumb CEO Pete Kadens to advisory board - KushCo Holdings (KSHB) announced that it has added Pete Kadens, the former CEO of Green Thumb Industries (GTBIF) to its Advisory Board. Kadens will provide guidance and mentorship on the company's strategic vision with corporate development and M&A activities to accelerate and maintain long-term profitable growth, the company said in a statement.
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SOLO TSLA | Hot Stocks08:51 EDT ElectraMeccanica appoints David Neace as director of sales - ElectraMeccanica Vehicles Corp. (SOLO) announced that David Neace is joining the Company as Director of Sales, to be based at the Company's flagship sales, service and distribution center in Los Angeles, California. Neace joins Meccanica with over 20 years of expertise in sales management, with his most recent role as Senior Program Manager at Tesla (TSLA), where he was key in creating both of the electric vehicle maker's Employee Delivery and Factory Direct programs.
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RCAR | Hot Stocks08:49 EDT RenovaCare appoints Robin Robinson as VP, scientific affairs - RenovaCare announced the appointment of its Vice President of Scientific Affairs, Dr. Robin Robinson. Notably, Dr. Robinson was appointed as Director of the Biomedical Advanced Research and Development Authority. At RenovaCare, Dr. Robinson will oversee and direct the Company's strategy, execution and engagement with government agencies, commercial research groups, academic institutions and select opinion leaders.
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EEVVF | Hot Stocks08:47 EDT Eve & Co announces new sales channel in Manitoba - Eve & Co Incorporated announced that it has been approved by the Manitoba Liquor and Lotteries Corporation to list non-medical adult-use cannabis throughout the province to licensed retailers approved for non-medical adult-use cannabis sales. The Company expects to begin shipping products to Manitoba in the next 4 weeks.
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PRSP | Hot Stocks08:46 EDT Perspecta awarded contract by U.S. NIWC Pacific - Perspecta announced that it was awarded a position on a multiple-award, cyberspace science, research, engineering and technology integration program from the U.S. Navy's Naval Information Warfare Center Pacific, or NIWC Pacific. The follow-on contract has a three-year base valued at $303 million, with two, two-year options and a maximum ceiling value of $740M, if all options are exercised. The scope of this program will include efforts to examine the architecture, engineering, functionality, interface and interoperability of Navy cyberspace operations systems, services and capabilities. Specifically, Perspecta will provide operational exercise design and construction, operations and requirements analysis, concept formulation and development, feasibility demonstrations and operational and technical support services. All work will be performed in San Diego, CA.
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BIEL | Hot Stocks08:43 EDT BioElectronics files FDA 510(k) application for expanded clearance for ActiPatch - BioElectronics Corporation announced that it has filed a 510(k), Premarket Notification application with the U.S. Food and Drug Administration. The application is to seek expanded market clearance for the drug free, over-the-counter ActiPatch Musculoskeletal Pain Therapy medical device for the indication: "adjunctive treatment of musculoskeletal complaints pain." The cervical osteoarthritis study submitted directly compares the effectiveness of ActiPatch treatment to that of a standard of care treatment: prescription NSAID therapy, Etoricoxib 60mg. Subjects were randomly assigned either to receive the Etoricoxib therapy or ActiPatch. Data from the study indicates that both treatments significantly reduced neck pain, but that ActiPatch was superior to NSAID treatment.
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MSI | Hot Stocks08:42 EDT Motorola Solutions patent infringement case against Hytera will proceed to trial - Motorola Solutions announced that its patent infringement case against Hytera of Shenzhen, China in the U.S. District Court for the Northern District of Illinois, which was previously stayed pending a decision from the International Trade Commission, or ITC, will proceed to trial. This follows the Illinois District Court's denial of Hytera's motion to dismiss on August 12 and its establishment of a pre-trial calendar, which includes pre-trial milestone and discovery dates, on August 15. The Illinois District Court patent infringement lawsuit asserts that Hytera's two-way radios, base stations, repeaters and dispatch systems are infringing seven patents owned by Motorola Solutions and that Hytera's "redesigned" i-Series products are infringing four of those patents. This case is separate from Motorola Solutions' trade secret theft and copyright infringement case against Hytera, which is also pending in the Illinois District Court and is expected to proceed to a jury trial in November. Hytera released the i-Series in response to the United States ITC's January importation ban and cease-and-desist orders that prevent Hytera from importing products into the United States that use three Motorola Solutions' patents: U.S. Patent Nos. 7,369,869; 7,729,701; and 8,279,991. Importantly for customers and end-users, because Hytera removed the features covered by those patents, its i-Series products lack significant and innovative features that enable safety, speed and efficiency in mission-critical communications.
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TJX | Hot Stocks08:41 EDT TJX down 3% or $1.55 at $50 after Q2 results, below-consensus Q3 EPS view
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SYNC | Hot Stocks08:41 EDT Synacor wins more than 300 Zimbra deals in Q2 - Synacor announced that Zimbra, the company's email and collaboration platform, added more than 100 new customers and expanded deals with 220 others during Q2.
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MLND | Hot Stocks08:38 EDT Millendo Therapeutics names Tamara Joseph general counsel, Ryan Zeidan CDO - Millendo Therapeutics announced the appointments of Tamara Joseph as general counsel and corporate secretary and Ryan Zeidan as chief development officer, or CDO. Joseph succeeds Jeffery Brinza who announced his retirement in March. Joseph joins Millendo with more than 20 years of leadership roles in multiple biotechnology companies, overseeing legal, compliance, public and government affairs, and risk management. She most recently served as general counsel at Enzyvant Therapeutics. Zeidan has served as senior VP of development at Millendo since joining the company in 2018. In this role he has overseen R&D functions including clinical operations, project management, CMC and regulatory affairs.
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HAS | Hot Stocks08:37 EDT Hasbro to phase out plastic from new toy, game packaging by end of 2022 - Hasbro announced that, beginning in 2020, it plans to begin phasing out plastic from new product packaging, including plastic elements like polybags, elastic bands, shrink wrap, window sheets and blister packs. The company's ambition is to eliminate virtually all plastic in packaging for new products by the end of 2022.
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TRIB | Hot Stocks08:37 EDT Trinity CEO says development of automated slide reader 'progressing well' - Ronan O'Caoimh, CEO of Trinity, said, "Revenues were down by $2.5m this quarter and whilst this was disappointing it was largely due to the fluctuating nature of our HIV revenues and to a lesser extent the reduction in the level of public health expenditure being allocated to HIV testing in the USA. On a more positive note our Clinical Laboratory revenues were broadly flat on a constant currency basis. As has been the case in all of our most recent quarters we have continued to see strong growth in our Diabetes and Autoimmunity product lines, although this growth was offset by lower Lyme and Fitzgerald revenues. I would like to highlight the company's strong R&D product pipeline which will be key to driving future revenue growth. In particular, our TrinScreen product, which will mark the company's entry into the $140m African HIV screening market, has the clear potential to transform the company from both a revenue and profitability perspective. Development of our new automated slide reader is progressing well and when launched will be a major boost to our already growing autoimmunity franchise. These come on the back of the Premier Resolution and Tri-Stat 2 product launches, which are already generating incremental haemoglobin revenues."
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BNED | Hot Stocks08:36 EDT Barnes & Noble Education enters partnership with VitalSource - Barnes & Noble Education announced a new agreement with VitalSource, part of Ingram Content Group. Under the agreement, VitalSource's technology will power the BNC FirstDay inclusive access platform, bringing together VitalSource's advanced technology and Barnes & Noble College's unparalleled campus and publisher relationships. "This partnership will drive affordability, access and achievement for students nationwide, making it easier for faculty members and academic leadership to implement an inclusive access solution on their campus. BNC FirstDay offers course materials at reduced prices through a course materials charge for participating programs. Students have the option to receive their materials on or before the first day of class, delivered seamlessly through their learning management system."
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TESS | Hot Stocks08:35 EDT Tessco appoints Sandip Mukerjee as CEO - Tessco (TESS) announced the appointment of telecom industry veteran Sandip Mukerjee as the company's president and CEO. Former CEO Murray Wright will retire following a transition period to ensure a smooth succession process. Mukerjee also has replaced Wright on the company's board. Mukerjee was most recently President, Global Professional & Consulting Services Business, Nokia Software (NOK).
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TJX | Hot Stocks08:35 EDT TJX reports Q2 gross margin 28.2% vs. 28.9% last year - The company says the decline was "primarily due to a decrease in merchandise margin and higher supply chain costs."
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OSS RTN | Hot Stocks08:35 EDT One Stop Systems receives $5.5M flash array order for radar application - One Stop Systems (OSS) has received purchase orders totaling $5.5M related to the previously announced $36M, five-year sole source supplier agreement with Raytheon (RTN). The agreement calls for OSS to supply flash storage systems with removable canisters that allow high-volumes of data to be easily transported from surveillance aircraft to ground stations. The systems will store real-time data collected from advanced airborne sensors, including radar and other sensors. The contract includes airborne and ground systems, spare canisters and support services.
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GIS | Hot Stocks08:35 EDT General Mills CFO Don Mulligan to retire, Kofi Bruce to succeed - General Mills announced changes to its senior leadership team. Don Mulligan, CFO, will transition to an advisory capacity effective February 1, 2020 and will retire effective June 1, 2020. Kofi Bruce, currently controller, will be promoted to VP, financial operations, effective September 1 and will succeed Mulligan as CFO on February 1, 2020. Mulligan has been with General Mills for 21 years in various finance leadership roles including responsibilities. Mulligan has held the CFO role since 2007 with overall company responsibility for worldwide finance, mergers and acquisitions, strategy, investor relations, external reporting, internal audit, tax and treasury. Bruce joined General Mills in 2009. Over his 10 years at General Mills, Bruce is known for his ability to work cross-functionally in developing and implementing creative, sustainable solutions to organization challenges.
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NUVA | Hot Stocks08:34 EDT NuVasive announces commercial launch of Modulus TLIF-A - NuVasive announced the commercial launch of Modulus TLIF-A, a porous titanium spine implant engineered for the transforaminal lumbar interbody fusion, or TLIF, procedure. This offering completes the Company's Advanced Materials Science, or AMS, portfolio for all major posterior interbody fusion techniques used in TLIF, the most commonly performed procedure in the spine industry. This solution increases the Company's footprint in the U.S. interbody device market, which is estimated to be more than $1.2B, and extends its entire AMS portfolio to a global patient audience with significant market share in anteriorly placed TLIF implants.1 Furthermore, the system is designed to work seamlessly with the Company's MAS(R) TLIF and MAS Midline access systems allowing customization options to specific surgical techniques.
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TJX | Hot Stocks08:34 EDT TJX CEO says Q3 off to a 'solid start' - CEO Ernie Herrman says: "We were very pleased that customer traffic drove our consolidated comp and was up at each of our four major divisions. This quarter marks the 20th straight quarter of customer traffic increases at TJX and Marmaxx. The third quarter is off to a solid start. We feel great about the terrific availability we are seeing in the marketplace for branded, quality merchandise and our ability to capitalize on the opportunities. We are excited about our many initiatives underway to keep driving sales and customer traffic throughout the fall and holiday selling season, and have great confidence in our potential to keep gaining market share around the world!"
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MYOV | Hot Stocks08:33 EDT Myovant Sciences completes patient recruitment for Phase 3 SPIRIT 2 study - Myovant Sciences announced that it has completed patient recruitment for its SPIRIT 2 study, the first of two Phase 3 replicate studies evaluating relugolix combination therapy in women with endometriosis-associated pain. The SPIRIT 2 study is part of an international clinical development program designed to gain regulatory approval of relugolix for the treatment of moderate-to-severe endometriosis-associated pain.
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TJX | Hot Stocks08:33 EDT TJX reports Q2 consolidated SSS up 2% - Reports Q2 SSS at Marmaxx up 2%, Home Goods flat, TJX Canada up 1%, and TJX International up 6%.
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HRTX | Hot Stocks08:31 EDT Heron Therapeutics announces results from EPOCH 2 Phase 3 study of HTX-011 - Heron Therapeutics announced that the results from EPOCH 2, a Phase 3 study of the investigational agent HTX-011 in open inguinal hernia repair surgery with mesh, have been published in the journal, Hernia, in an article entitled "HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in herniorrhaphy: results from the phase 3 EPOCH 2 study." HTX-011 achieved all primary and key secondary endpoints in EPOCH 2, demonstrating statistically significant reductions in both pain intensity and the use of opioid rescue medications following surgery and an increase in the proportion of patients who were opioid-free. Heron has completed two pivotal Phase 3 studies of HTX-011: EPOCH 1 in bunionectomy, which is a study of a bony tissue surgical model, and EPOCH 2 in hernia repair, which is a study of a soft tissue surgical model.
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DPDW | Hot Stocks08:29 EDT Deep Down receives Kaikias Riser Isolation Valve system order - Deep Down announced that it has received an order from Shell for work related to its Kaikias development in the U.S. Gulf of Mexico. The order is for the design, engineering, manufacturing and installation of a Riser Isolation Valve control system on the Ursa tension-leg platform. The Ursa TLP is located in the Mississippi Canyon Block 810, approximately 130 miles from the coast of Louisiana, in water depth of 4,500 ft. The Riser Isolation Valve control system will be installed on the TLP to provide shutdown of production fluids.
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RNET | Hot Stocks08:27 EDT Ocyan signs multi-year agreement with RigNet for Intelie Live - RigNet announced that Ocyan, one of Brazil's largest providers of solutions for the upstream oil and gas industry, has signed a multi-year agreement and selected Intelie Live, RigNet's machine learning-based analytics platform, to be used at their Drilling and Marine Operational Support Center. Ocyan's system will use Intelie as an integrated monitoring system for the company's entire fleet of drilling rigs.
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CGIX | Hot Stocks08:25 EDT Cancer Genetics says continuing to explore strategic alternatives
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TEVA ATRS | Hot Stocks08:24 EDT Teva announces availability of EpiPen Jr generic equivalent - Teva (TEVA) announced availability of the FDA-approved generic version of EpiPen Jr auto-injector, 0.15 mg, in the U.S. The product is available in most retail pharmacies, and the wholesale acquisition Cost is $3002 for a 2-pack. Currently, one in nine generic prescriptions dispensed in the U.S. is filled with a Teva product. Teva's generic equivalent of EpiPen and EpiPen Jr utilize the Antares Pharma (ATRS) Vibex device. Antares and Teva have an exclusive license, development and supply agreement for epinephrine auto injector products that Teva markets in the U.S.
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PUFXF | Hot Stocks08:21 EDT Agraflora Organics to acquire 50% of Eurasia Infused Cosmetics - AgraFlora Organics International announced that the Company has entered into a definitive agreement to acquire 50 per-cent of the issued and outstanding shares of Eurasia Infused Cosmetics. AgraFlora and Eurasia will collaborate to integrate the Company's vertically integrated, farm-to-face CBD processing, manufacturing and distribution model into the Asia Pacific region. Eurasia Infused, by way of a commercial concession with Hong Kong domiciled CBD Group Asia Limited controls a distribution agreement for CBD and hemp-derived beauty and wellness products for the territories of People's Republic of China and Hong Kong Special Administrative Region. The distribution agreement extends to AgraFlora's diverse portfolio of CBD-infused and/or hemp-oil-derived CPG personal care products, for which CBD Group Asia will have an exclusive for sales in China, including but not limited to: CBD-infused cosmetics; Hemp body soaps; Hemp-derived lotions and skin serums; and, CBD-infused sunscreen. AgraFlora and CBD Group Asia have commenced collaboration on a variety of product customization and distribution initiatives for its Whole Hemp Health line of all natural skin care products, with the objective of tailoring the Company's product offering for rapid uptake into the Asian CPG markets. The Company's Whole Hemp Health product line derived from 100 per-cent organic Canadian hemp seed oil and is presently marketed by way of brick-and-mortar retail outlets, Amazon Prime, as well as direct to consumer, through an integrated Shopify e-commerce platform. Under the terms of the Securities Purchase Agreemen AgraFlora will acquire 50 per cent of the issued and outstanding shares in the capital of Eurasia Infused, in exchange for an aggregate of 15 million common shares in the capital of the Company, based upon the five-day volume-weighted average price of AgraFlora common shares for the five trading sessions prior to the announcement of the definitive agreement. The closing of this acquisition is subject to customary terms and conditions.
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CVET | Hot Stocks08:20 EDT Covetrus offers APPE to UNE pharmacy doctoral candidates - Covetrus announced that it is partnering with the University of New England's College of Pharmacy, or UNE, by offering an advanced pharmacy practice experience, or APPE, to pharmacy doctoral candidates enrolled there. This program is one of many university partnerships that Covetrus has sponsored or developed in pursuit of its mission to advance the world of veterinary medicine. The Covetrus APPE, also known as a "rotation," allows pharmacy students to gain experience and skills, by delivering pharmaceutical and other animal-health related work supervised by members of the Covetrus global prescription management pharmacy team. Covetrus' APPE curriculum includes practical experience with veterinary pharmacology, as well as other topics, such as the application of pharmacy law in the veterinary space. Students will have the option to gain hands-on experience at the new Covetrus pharmacy, which is located within miles of the UNE campus.
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DUOT | Hot Stocks08:16 EDT Duos Technologies Group awarded $1M contract for AI algorithms - Duos Technologies Group has been awarded an expanded contract with a Class 1 freight railroad for an estimated initial value of approximately $1M in recurring revenue to be recognized over the five-year life of the contract. The award provides for an initial library of Artificial Intelligence based algorithms which will analyze images from the Company's rail inspection portal for maintenance inspection of the customer's railcars.
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VRTX | Hot Stocks08:16 EDT Vertex announces FDA acceptance of VX-445 NDA - Vertex announced the FDA accepted its new drug application, or NDA, for the VX-445, tezacaftor and ivacaftor triple combination regimen. The FDA has granted Priority Review of the NDA and assigned a Prescription Drug User Fee Act, or PDUFA, target action date of March 19. The submission was supported by previously disclosed positive results of two global Phase 3 studies in people with cystic fibrosis, or CF: a 24-week Phase 3 study in people with one F508del mutation and one minimal function mutation and a 4-week Phase 3 study in people with two F508del mutations. Both Phase 3 studies showed statistically significant improvements in lung function, which was the primary endpoint, and in all key secondary endpoints. In these studies, the triple combination regimen was generally well tolerated.
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STOK | Hot Stocks08:16 EDT Stoke Therapeutics enrolls first patient in BUTTERFLY observational study - Stoke Therapeutics announced enrollment of the first patient in an observational study of children and adolescents ages 2 to 18 with Dravet syndrome. Dravet syndrome is a severe and progressive genetic epilepsy characterized by frequent, prolonged and refractory seizures, beginning within the first year of life. The effects of the disease go beyond seizures and often include cognitive regression or developmental stagnation, ataxia, speech impairment and sleep disturbances. BUTTERFLY is a two-year observational study that is designed to evaluate seizure frequency and non-seizure comorbidities associated with the disease, including motor and speech impairment, intellectual and developmental disabilities, behavioral deficits and abnormal sleep patterns. Data from the study will support clinical development plans for the company's lead therapeutic candidate, STK-001, an investigational new treatment for Dravet syndrome.
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OHGI | Hot Stocks08:14 EDT One Horizon CEO expects to add more Touchpoint license revenue before year end - Mark White, Chief Executive Officer of One Horizon, stated, "We made significant progress during the second quarter by introducing a new offering developed from our 123Wish Platform. Specifically, we launched Touchpoint, a next generation fan engagement platform designed to bring fans closer to celebrities by providing access to proprietary content, livestream events, as well as exclusive merchandise. We added elite model, Alexis Clark, as our first celebrity influencer to maximize engagement with her growing fan base and sponsors. We are expecting the commercial launch of Maham LLC's yoga version of Touchpoint in the coming weeks, which will enable Maham to offer on-line and offline yoga classes, exclusive content and merchandise on the app. The platform is optimized for iOS and Android, as well as Internet and TV-based applications. Moreover, we plan to leverage other celebrity relationships through our 123Wish Platform, which we believe will help Touchpoint rapidly gain critical mass. Touchpoint is targeted to fans and brands and we expect to rapidly add more license revenue before the year end. We are also moving forward with our preliminary agreement to acquire a majority interest in Redspots Creative Hong Kong, a pioneer in the area of augmented/virtual reality that has developed the first virtual idol animation system aimed at both the end user and professional animators. As the AR/VR market is experiencing significant growth, we anticipate this planned acquisition to be transformational to our business and easily leveraged across our media and digital technology platforms, including Love Media House, Browning Productions and 123Wish. We believe this transaction will be accretive to earnings and our interests are closely aligned with Redspots on several levels including the purchase price, which is based on Redspots achieving future earnings targets. Although this transaction has taken longer than anticipated to close, we are making steady progress and look forward to providing further updates. Browning Productions has made significant advances with 'Wine Warriors' and spin-offs into the beverage and spirits space. The first season of Wine Warriors, which is 12 episodes, is now available on Amazon Prime. In addition, a spin-off titled 'Whisky Warriors' is currently in pre-production and is scheduled to launch later this year. These are expected to bring significant revenues before the year end. We have significantly refined our business model, which we believe provides a platform for sustained growth in future quarters. At the same time, we are carefully managing our expenses, reflected in the reduced net loss for the second quarter of 2019. As a result, we believe we have built a highly scalable business model with the potential to drive significant value for shareholders for years to come."
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TDY | Hot Stocks08:11 EDT Teledyne Optech, LiDAR USA partner for mobile UAV sensor integration - Teledyne Optech has announced that its new compact lidar sensor, the CL-90, is available for purchase through its first integration partnership with LiDAR USA. Teledyne Optech's CL-90 sensor features exceptional canopy penetration for excellent ground coverage, much higher downward point density for superior results in corridor/power line projects, long-range performance for maximum productivity at UAS ceilings, and best-in-class data precision for tight-tolerance applications; an ideal companion to LiDAR USA's robust and dynamic integration capabilities.
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AMAG | Hot Stocks08:09 EDT Amag Pharmaceuticals announces grant of inducement awards - AMAG Pharmaceuticals announced that the Board of Directors of AMAG approved inducement awards to a new employee of an option to purchase 16,700 shares of common stock and 8,500, restricted stock units. The option will have an exercise price equal to the closing price of AMAG's common stock on the grant date and will be exercisable in four equal annual installments beginning on the first anniversary of August 19, 2019. The option will have a ten-year term and be subject to the terms and conditions of the stock option agreement pursuant to which the option will be granted. The restricted stock units will vest in three equal annual installments beginning on the first anniversary of the grant date and will be subject to the restricted stock unit agreement pursuant to which the restricted stock units will be granted. These equity awards will be granted without stockholder approval as inducements material to the employee entering into employment with AMAG in accordance with NASDAQ Listing Rule 5635(c)(4).
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NCNA | Hot Stocks08:07 EDT NuCana announces suspension of enrollment in Phase III ACELARATE study - NuCana reported that it has been informed by the Clatterbridge Cancer Centre, the sponsor of the ongoing Phase III ACELARATE study, that the enrollment of new patients has been suspended on the advice of the Independent Safety and Data Monitoring Committee following completion of a prespecified futility analysis. This study has enrolled 200 patients with metastatic pancreatic cancer who were not considered suitable for combination chemotherapy and is designed to evaluate the efficacy and safety of Acelarin monotherapy compared to gemcitabine, with further exploration of patient sub-groups that may derive additional benefit from Acelarin. A futility analysis was included in the ACELARATE study design to assess the likelihood of the study achieving its primary objective of Acelarin monotherapy demonstrating at least a 42% reduction in risk of death compared to gemcitabine. This analysis indicated that this efficacy objective was unlikely to be met in this difficult to treat patient population. Upon review of the interim data by the ISDMC, the sponsor decided to suspend recruitment, allow the data to mature and conduct additional sub-group analyses. Patients who are deriving benefit can continue treatment with Acelarin. There are 25 patients who are receiving or have received Acelarin monotherapy and who will continue to be followed by the study sponsor.
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BYND | Hot Stocks08:06 EDT C.A. Fortune announces National Sales Agency partnership with Beyond Meat - C.A. Fortune announced its newest client, Beyond Meat. The partnership will officially take effect on September 1. C.A. Fortune has a significant amount of experience in representing plant-based and alternative protein clients and will use that expertise to support the Beyond Meat business with most retailers across the United States.
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OTLK | Hot Stocks08:05 EDT Outlook Therapeutics completes patient enrollment for NORSE 1 Phase 3 trial - Outlook Therapeutics announced that it has completed patient enrollment in the NORSE 1 Phase 3 clinical trial, which is evaluating ONS-5010 against ranibizumab for wet AMD. NORSE 1 has enrolled a total of 61 patients at 9 sites in Australia. The study is the first of two ongoing, adequate and well controlled Phase 3 clinical trials evaluating ONS-5010 against ranibizumab for wet AMD. The endpoint for the study is a mean change in baseline visual acuity at 11 months for ONS-5010 dosed on a monthly basis compared to ranibizumab dosed using the PIER alternative dosing regimen of three monthly doses followed by quarterly dosing. The Company expects to announce a readout of the topline results from NORSE 1 in the third quarter of calendar 2020. If the ONS-5010 clinical program is successful, it will support the Company's plan to submit for regulatory approval in multiple markets in 2020. If approved, ONS-5010 has potential to mitigate risks associated with off-label use of Avastin or other drugs. Off label use of Avastin is currently estimated to account for at least 50% of all wet AMD prescriptions in the United States.
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BTAI | Hot Stocks08:04 EDT BioXcel Therapeutics awarded grant by U.S. DoD for BXCL501 development - BioXcel Therapeutics announced that the U.S. DoD's CDMRP has awarded a planning grant as a part of its Alcohol and Substance Abuse Disorders Research Program related to the development of the Company's product candidate, BXCL501. The grant will support the development of a clinical study to evaluate the use of BXCL501 for the treatment of ASUD, particularly related to PTSD and TBI. This study will be led by principal investigator John Krystal, M.D., the Robert L. McNeil, Jr. Professor of Translational Research, the Chairman of the Yale Department of Psychiatry, the Chief of Psychiatry at Yale-New Haven Hospital and the Director of Clinical Neurosciences, National Center for PTSD. The Company recently announced positive top-line results from its adaptive Phase 1b, randomized, double-blind, placebo-controlled, multi-center, U.S. trial, evaluating multiple doses of BXCL501, an investigational selective and potent alpha2-adrenergic receptor agonist, for acute treatment of agitation in 135 patients with schizophrenia. Based on these results, the Company is planning to initiate Phase 3 pivotal trials in Q4 2019. The results from this study of BXCL501 suggest that it may merit further evaluation in patients with ASUD correlated with PTSD and TBI, experiencing hyper-arousal and high sympathetic nervous system activity. BXCL501 may be evaluated for use as an adjunct therapeutic before, during or after exposure therapy/
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SOLY | Hot Stocks08:03 EDT Soliton announces results from preclinical studies of RAP treatment - Soliton announced results of preclinical studies which reveal its RAP device appears to deliver increased disruption of the fibrotic septa that contribute to the appearance of cellulite with increased treatment time, implying a dose response to the therapy. The new discovery, referred to as "acoustic subcision," helps explain the recent proof-of-concept, or POC, trial results, which demonstrated a 20-47% improvement in the patient's Cellulite Severity Score following the use of the Company's RAP device. The RAP device for the treatment of cellulite is investigational and not available for sale in the United States.
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MRSN | Hot Stocks08:03 EDT Mersana Therapeutics intitiates expansion portion of Phase 1 study of XMT-1536 - Mersana Therapeutics announced the dosing of the first patient in the expansion portion of the Phase 1 study of XMT-1536, its first-in-class, wholly-owned Dolaflexin ADC targeting NaPi2b. The expansion cohorts will assess the efficacy, safety and tolerability of XMT-1536 at 36 mg/m2 every four weeks in patients with platinum-resistant ovarian cancer and non-small cell lung cancer adenocarcinoma. The Company also announced that it has not determined a maximum tolerated dose and that it plans to continue the dose escalation portion of the study in parallel. The expansion study includes two patient cohorts. One is enrolling platinum-resistant ovarian cancer patients who have failed standard therapy and have had no more than three lines of prior therapy. The other cohort is enrolling NSCLC adenocarcinoma patients who have failed front line platinum-based chemotherapy, either in combination or sequentially treated with an anti-PD-1 or anti-PD-L1 therapy. Patients in the expansion portion of the XMT-1536 Phase 1 study will be treated with the 36 mg/m2 once-every-four-week dosing regimen. Patients will not be pre-selected for NaPi2b expression, but eligibility criteria require archived tumor samples and fresh tumor biopsies when medically feasible.
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EIGR | Hot Stocks08:02 EDT Eiger BioPharmaceuticals receives FDA BTD for for peginterferon lambda - Eiger BioPharmaceuticals announced that the FDA has granted Breakthrough Therapy Designation for peginterferon lambda for the treatment of hepatitis delta virus infection.
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LIQT | Hot Stocks08:02 EDT LiqTech announces SPA to acquire BS Plastic - LiqTech International announced the signing of a Share Purchase Agreement, or SPA, to acquire BS Plastic, a specialized plastics manufacturer based in Denmark. The acquisition allows LiqTech to in-source certain components of its proprietary and market-leading ceramic silicon carbide water filtration systems for closed loop marine scrubber applications. The acquisition is expected to close in the Q3.
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VST | Hot Stocks08:00 EDT Vistra Energy to acquire Ambit Energy for $475M - Vistra Energy announced it has entered into an agreement to acquire Ambit Energy for $475M plus net working capital in an all-cash transaction. Following the closing of the transaction, Vistra's share of the ERCOT residential market will grow from approximately 25% to approximately 32% and an industry-leading 26% in all U.S. competitive markets. Ambit is headquartered in Dallas, Texas and serves approximately 1.1M residential customer equivalents in 17 states. The North Texas overlap of administrative functions will uniquely position Vistra to capture synergies and enable the teams to quickly integrate operations. Vistra expects the Ambit business will contribute approximately $125M to adjusted EBITDA after the full run-rate of approximately $25M of anticipated annual synergies is achieved.
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CNET | Hot Stocks07:41 EDT ChinaNet CEO says will continue to integrate blockchain, AI tech into products - CEO Handong Cheng, "Our previously announced private placement agreement with strategic investors will help to shore up our capital position going forward and provide us with future growth opportunities. We plan to leverage the commercial and technological resources of strategic investors to supercharge our business development initiatives and, in doing so, propel our launch into a new growth cycle. We are excited to explore the synergies between both parties' resources and optimistic regarding our potential to grow new, profitable lines of businesses through these collaborations both in China and on a global scale. Such international expansion will help to reduce our exposure to the current risks throughout the domestic market as well as enable us to better support small and medium-sized companies in China to meet and overcome this same macroeconomic uncertainty through our products and services. We will continue to integrate blockchain and AI technology within our products and services for advertising, marketing, and data analytics. Such integration will take the scope of our business to the next level, improve our margin, and increase our revenue streams over the long-term. Within China and throughout Asia, there are many opportunities to support small and medium-sized companies in an increasingly uncertain economic environment. Going forward, we will continue leveraging our deep industry experience and close business relationships to serve these organizations and address their pain points. Furthermore, we remain committed to bolstering our management and refining our cost structure. In July, we appointed Mr. Mark Li as our new Chief Financial Officer. With extensive leadership and operational experience in financial management, we are confident that Mr. Li will be a great asset for us as we continue to optimize our current operations and expand our data and blockchain businesses."
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VVUS | Hot Stocks07:36 EDT VIVUS says study shows addition of Qsymia to LSG surgery improved weight loss - VIVUS announced the results of a pilot clinical study demonstrating that patients receiving Qsymia capsules CIV before and after laparoscopic sleeve gastrectomy surgery lost more weight and had a greater probability of achieving a body mass index of less than 40 compared with patients undergoing surgery alone without anti-obesity medication. The study was conducted at the Wake Forest School of Medicine and the results appear in the current issue of Surgery for Obesity and Related Diseases. In addition to increased surgical risk, patients with a BMI of 50 or greater are likely to have a BMI of 40 or greater even after successful surgery. Physicians often address this issue by offering patients a two-stage weight loss process that involves an initial LSG followed by a second surgical procedure after initial post-LSG weight loss. Treatments that allow patients to achieve BMI of less than 40 after the initial LSG could reduce the need for a second surgical procedure, decreasing health risks and costs. The pilot study recruited 25 participants with a BMI of 50 or more who were planning to undergo LSG. Patients in the control group had a BMI of 50 or more and underwent LSG in the same timeframe but were not included in the study protocol. Patients in the experimental arm received Qsymia at a dose of 3.75/23 mg once daily for two weeks, which was then increased to 7.5/46 mg or 15/92 mg daily in order to achieve the greatest weight loss with the fewest side effects. Patients tapered off the medication beginning two weeks prior to surgery in order to avoid potential interactions between phentermine and anesthesia and resumed dosing at 7.5/46 mg daily one month following LSG, with dose adjustments made monthly over the next two months. Patients then continued to utilize Qsymia for a 24-month period. Key findings from the study include: The experimental group had a baseline BMI of 61.2 +/- 7.1 kg/m2 compared with 57.0 +/- 5.6 kg/m2 for control participants. At 24 months, the mean BMI was 33.8 kg/m2 for the experimental group vs. 42 kg/m2 for control participants. Of the 25 patients recruited, 13 completed LSG. Patients who did not complete LSG were due to: medical complications unrelated to Qsymia, decision not to pursue surgery, Qsymia-related adverse events, because they were lost to follow-up and withdrawn from the study or opted to undergo a surgical procedure other than LSG. Patients in the experimental arm lost more than twice the weight with an average of 28.1 kg during the pre-operative period compared with an average of 12.3 kg for those in the control group. At two years post-LSG, the experimental group lost 11.2% more of initial body weight compared with controls, which translates to a -18.2% difference in percent excess weight loss (%EWL) of favoring the experimental group. A higher proportion of patients in the experimental group compared with controls achieved a BMI less than 40 at 3, 6, 12 and 24 months post-LSG. There was a significant increase in the odds of achieving BMI less than 40 for the experimental group compared with controls at 6 months post-LSG; at 24 months the odds ratio remained 4.1 but was no longer statistically significant. The study authors conclude that for patients with a BMI of 50 or more the combination of LSG and phentermine/topiramate ER had a robust impact on patients both before and for up to two years after LSG surgery.
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DOW | Hot Stocks07:34 EDT Dow Inc. to retrofit Louisiana cracker with FCDh technology to produce propylene - Dow announced it will retrofit proprietary fluidized catalytic dehydrogenation, or FCDh, technology into one of its mixed-feed crackers in Plaquemine, Louisiana, to produce on-purpose propylene. The retrofit will enable Dow to continue to meet growing demand for its businesses serving consumer, infrastructure and packaging end-markets, while also remaining within its stated near-term capital expenditure targets. In 2016, Dow expanded the ethylene capacity of this same cracker by more than 225,000 metric tons and added the ability to crack ethane, while maintaining the flexibility to crack propane, butane and naphtha. Dow and other U.S. cracker operators are consuming more ethane instead of heavier feed slates, resulting in a reduction of coproduct production, including propylene. This reduction in propylene has created a supply/demand gap in the U.S. that requires additional on-purpose propylene sources to meet the needs of downstream derivatives. The FCDh technology retrofit further improves Dow's ability to continue to source the most advantaged feedstocks, while also producing on-purpose propylene to supply its integrated derivative units in Louisiana. The technology can also reduce capital outlay by up to 25% and lower energy usage and greenhouse gas emissions by up to 20%, thereby improving overall sustainability when compared to conventional propane dehydrogenation technologies. The retrofit will enable production of more than 100,000 metric tons of additional on-purpose propylene at full run-rate, further back-integrating Dow's derivative facilities to cost-advantaged propylene while also maintaining the unit's current ethylene production capacity. The project is expected to begin producing on-purpose propylene by the end of 2021.
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BIIB NVTA | Hot Stocks07:32 EDT Biogen, Invitae announce availability of SMA STAT test - Biogen (BIIB) and Invitae Corporation (NVTA) announced that SMA STAT, a new, rapid-turnaround genetic test for spinal muscular atrophy, will be offered at no charge to individuals in the U.S. as part of the SMA Identified program. The SMA STAT test reduces the time needed for genetic testing to help confirm a definitive diagnosis of SMA from 21 to four days, enabling individuals and physicians to plan and begin treatment earlier for what is often a life-threatening disease. Clinical studies have demonstrated that early diagnosis and treatment of SMA may prevent the development of severe symptoms, improve motor function and slow the progression of the disease. A preliminary diagnosis of SMA is typically made through a physician assessment after an individual has developed symptoms, although a diagnosis can also be made through newborn screening. Genetic testing confirms an SMA diagnosis and provides more information that can be used to help guide treatment and care planning decisions. The SMA STAT test detects deletions in the SMN1 gene and assesses copy number of the SMN2 gene, both essential pieces of information for diagnosing and treating SMA. The presence of a greater number of SMN2 copies is generally associated with less severe but still life altering forms of the disease.
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MBRX | Hot Stocks07:32 EDT Moleculin Biotech receives Emory University CTRC approval for WP1066 trial - Moleculin Biotech announced approval by the Emory University Clinical Trial Review Committee, or CTRC, to move forward with an Investigator Initiated clinical trial of Moleculin's immune-stimulating/transcriptional-modulator, WP1066, for the treatment of pediatric brain tumors. The trial will take place at the Aflac Cancer and Blood Disorders Center at Children's Healthcare of Atlanta.
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QCOM | Hot Stocks07:31 EDT Qualcomm, LGE enter new global patent license agreement - Qualcomm announced that LGE has entered into a new direct worldwide patent license agreement with Qualcomm. Under the terms of the five-year, royalty-bearing agreement, Qualcomm has granted LGE a patent license to develop, manufacture and sell 3G, 4G and 5G single-mode and multimode complete devices. The agreement is consistent with Qualcomm's established global licensing terms.
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ENTX | Hot Stocks07:24 EDT Entera Bio to report results from Phase 2b study for oral PTH in September - The company said, "Phase 2b Study for Oral PTH in hypoparathyroidism: Oral PTH for hypoparathyroidism is Entera's second major proprietary pipeline program. Entera completed in 2018 a two-part Phase 2 trial in patients with hypoparathyroidism that was designed to evaluate the pharmacokinetic and pharmacodynamic profiles of its oral PTH drug and injectable PTH. Results from Part 1 of this study, reported in 2018, demonstrated a positive impact of Oral PTH on three metabolic parameters - serum calcium, phosphate, and 1,25-dihydroxyvitamin D - in patients with hypoparathyroidism. There was also a decrease in 24-hour urine calcium in the patients treated with Oral PTH. Part 2 of this PK/PD study evaluated a three times per day treatment regimen with a high and low dose of Oral PTH, as well as additional Natpara treatments. Results from this study are expected to be reported in September 2019 at an upcoming scientific conference and are subsequently expected to be submitted for peer review publication in 2020. These data will provide input for the design of the Company's anticipated Phase 3 registration clinical trials."
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ENTX | Hot Stocks07:22 EDT Entera Bio expects to complete enrollment for Phase 2 study for oral PTH in 1Q20 - The company said, "Phase 2 Study for Oral PTH in osteoporosis: The overall design and registration requirements for the planned pivotal Phase 3 study have been largely defined following the input from the U.S. Food and Drug Administration in our pre-IND meeting held in 2018. Coupled with the vast clinical experience with the marketed PTH injection, the Company initiated a dose-ranging, placebo-controlled, Phase 2 study in June 2019. This study will enroll 160 postmenopausal women with osteoporosis or low bone mineral density at four internationally recognized clinical sites in Israel. The primary endpoint of this study is bone formation biomarkers at 3 months with an additional evaluation at 6 months, of bone mineral density. The first patients were recently enrolled, with recruiting and screening efforts underway at all sites. The Company expects enrollment to be completed in the first quarter of 2020, with results from this Phase 2 expected starting in 2020, the first being the interim 3-month biomarker data, followed by the full 3-month and 6-month biomarker data, per the approved study design. These biomarker data, along with the bone mineral density data expected at 6 months, will inform the design of our registrational Phase 3 study. This registrational study is expected to be substantially smaller and less costly than studies used for previously studied PTH products, where the FDA required a fracture endpoint, which historically require thousands of patients over a number of years."
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ENTX | Hot Stocks07:19 EDT Entera Bio CEO says continuing 'to execute' on two lead PTH programs - "Entera's evolution into one of the leading oral delivery companies for human parathyroid hormone and other biologics or large molecule drugs continues at a rapid pace. For our internal proprietary Phase 2 therapeutic pipeline, we continue to execute on our two lead PTH programs with a number of near-term milestones over the coming year," stated Adam Gridley, CEO of Entera. "We are pleased to advance our lead program in osteoporosis with the recent initiation of a Phase 2 dose ranging study for EB613, our oral PTH candidate. Given the potential commercial potential for an orally delivered drug for osteoporosis, and the recent FDA guidance on endpoints via the 505(b)2 regulatory pathway, we've accelerated our clinical efforts for this program. This study is designed to build upon the strong safety and efficacy data generated to date, and inform the appropriate dose to evaluate for our global registrational Phase 3 study to support potential FDA review. We have also completed Part 2 of our Phase 2 PK/PD study of Oral PTH in hypoparathyroidism, and we plan to present them at a scientific meeting in the third quarter of 2019. In addition to executing on our lead development programs, our strategic priorities over the next 12 months will encompass a concerted investor relations outreach strategy and executing on a holistic business development initiative to drive shareholder value. To that end, we are excited by the opportunity to expand on the work we are doing in our partnership with Amgen, and with other leading biotechnology and pharmaceutical companies to apply our novel technology platform to other efficacious injectable products that may benefit from oral delivery. We currently see three main areas for potential partnerships: companies with leading injectable franchises that are now facing a growing threat from biosimilars, biologics and proteins that may prove to be complementary to our oral delivery platform, as demonstrated by the strategic research collaboration we signed with Amgen in 2018, and opportunities to license EB613 or EB612 globally, or in certain regions of Asia with the goal of rapidly developing and commercializing these products globally."
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TRLFF | Hot Stocks07:15 EDT True Leaf launches CBD chews for U.S. pet health market - True Leaf Brands announced the launch of its veterinarian-formulated, cannabidiol supplements for dogs at SuperZoo 2019 in Las Vegas, Nevada. True Leaf's CBD product line will begin rolling out on September 30, 2019, to pet retail stores in several U.S. jurisdictions and the Company's online store at www.trueleaf.com.
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TNXP | Hot Stocks07:13 EDT Tonix Pharmaceuticals expands preclinical pipeline with TNX-1600 - Tonix Pharmaceuticals Holding announced an exclusive agreement to in-license a triple reuptake inhibitor, TNX-1600, to treat posttraumatic stress disorder and potentially other central nervous system disorders. The compound was developed and pharmacologically characterized by Aloke Dutta, Ph.D., professor of Pharmaceutical Sciences at Wayne State University, with funding from a National Institutes of Health grant, and the patents covering the compounds were licensed to TRImaran Pharma. The transaction announced is a license agreement with Wayne State and an asset acquisition with TRImaran. Under the terms of the agreement, Tonix has been granted an exclusive license from Wayne State University for technology and patents related to TNX-1600 and other pyran-based compounds. Another member of the class, D-473, has also shown effects in a rodent model of depression.
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AXSM AMGN | Hot Stocks07:09 EDT Axsome Therapeutics appoints David Marek as CCO - Axsome Therapeutics (AXSM) announced the appointment of David Marek as chief commercial officer, effective August 31, 2019. Marek joins Axsome from Amgen (AMGN), where he was VP, and General Manager of Amgen's Neuroscience business unit.
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QURE | Hot Stocks07:07 EDT uniQure eliminates COO role, Scott McMillan to retire - uniQure announced the promotions of Sander van Deventer, M.D., Ph.D., to EVP, Research and Product Development, and Alex Kuta, Ph.D., to EVP, Operations, effective immediately. As a result of these changes, the Company is eliminating the COO role, and Scott McMillan, Ph.D., will be retiring from uniQure. In Dr. van Deventer's new role as EVP, Research and Product Development, he is responsible for the Company's gene therapy research activities, as well as nonclinical development, process development, analytical development and vector development. Dr. van Deventer will continue to serve as General Manager of uniQure's Amsterdam research and technology center of excellence. In Dr. Kuta's new role as EVP, Operations, he is responsible for global quality and regulatory affairs, as well as GMP manufacturing at uniQure's state-of-the-art facility in Lexington, Massachusetts. Dr. van Deventer joined uniQure as Chief Scientific Officer and General Manager, Amsterdam in August 2017. Dr. Kuta joined uniQure in January 2017 as Senior Vice President, Regulatory Affairs with more than 30 years in the biotechnology field.
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CMCM | Hot Stocks07:06 EDT Cheetah Mobile reports Q2 global mobile MAUs 376.5M - The average number of global mobile monthly active users was 376.5M in the second quarter. The number of Mobile MAUs from markets outside of China, or overseas markets, accounted for 74.2% of the total number of Mobile MAUs in the second quarter.
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CMCM | Hot Stocks07:04 EDT Cheetah Mobile announces special cash dividend of 50c per ADS - Cheetah Mobile announced that the company's board of directors approved a special cash dividend of 50c per American Depositary Share, or 5c per ordinary share. The cash dividend will be paid on September 30 to shareholders of record at the close of business on September 13.
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CGC | Hot Stocks07:02 EDT Canopy Growth receives new Health Canada licence for KeyLeaf facility - Canopy Growth is pleased to announce that it has received a licence from Health Canada for its KeyLeaf Life Sciences facility in Saskatoon, Saskatchewan. Including the Smiths Falls site and the recently licensed BC Tweed extraction site, Canopy Growth now operates three significant extraction assets to support the throughput required for large scale value-add product development. Canopy Growth recently retrofitted the now fully licensed KeyLeaf facility in Saskatchewan, a company with over 50 years of experience in the extraction industry. This facility is expected to be online in the Fall of 2019 and has the capacity to extract up to 5,000 kilograms of hemp or cannabis biomass per day. The application for the licence was submitted under KeyLeaf's previous name, POS Management Corp. and will be updated in due course. The newly-licensed extraction platform is located in close proximity to Canopy Growth's large-scale outdoor hemp and cannabis grow operations. The company looks forward to the additional capacity increasing production efficiency, augmenting output volume, and ultimately reducing operational costs for value-add products set to be rolled out in the Canadian recreational and medical markets at the end of calendar year 2019.
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CLDC | Hot Stocks07:02 EDT China Lending receives not in compliance notice from Nasdaq - China Lending announced that it received a notification letter from Nasdaq Listing Qualifications advising the Company that based upon the closing bid price for the Company's common shares for the past 30 consecutive business days, the Company no longer met the minimum $1.00 per share Nasdaq continued listing requirement set forth in Nasdaq Listing Rule 5555. The notification also stated that the Company would be provided 180 calendar days, or until February 11, 2020, to regain compliance with the foregoing listing requirement. To do so, the bid price of the Company's common stock must close at or above $1.00 per share for a minimum of 10 consecutive business days prior to that date.
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AZN | Hot Stocks06:55 EDT AstraZeneca reports Farxiga met primary endpoint in Phase 3 DAPA-HF trial - AstraZeneca announced results from the landmark Phase III DAPA-HF trial, which showed that Farxiga met the primary composite endpoint with a statistically-significant and clinically-meaningful reduction of cardiovascular death or the worsening of heart failure, compared to placebo. The trial was conducted in patients with reduced ejection fraction on standard of care treatment, including those with and without type-2 diabetes. The safety profile of Farxiga in the DAPA-HF trial was consistent with the well-established safety profile of the medicine. The full DAPA-HF trial results will be submitted for presentation at a forthcoming medical meeting. Farxiga is also being studied in patients with heart failure with preserved ejection fraction in the DELIVER and DETERMINE trials.
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MDT | Hot Stocks06:48 EDT Medtronic CEO says Q1 'a good start to our fiscal year' - "Medtronic had a solid first quarter, delivering revenue growth, operating margin expansion, and adjusted EPS growth all ahead of expectations," said Omar Ishrak, Medtronic chairman and CEO. "It's a good start to our fiscal year. As a result of our first quarter outperformance and confidence in our outlook, we are raising our full year EPS guidance," said Ishrak. "We're excited about what lies ahead, as we expect the investments we've made in our pipeline to begin to pay off with multiple pipeline catalysts, accelerating revenue growth, and value creation for our shareholders."
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SE | Hot Stocks06:42 EDT Sea Limited reports Q2 QAUs of 310.5M, up 93.3% - Quarterly active users, or QAUs, reached 310.5M, an increase of 93.3% year-on-year from 160.6M for Q2 of 2018. Q2 average revenue per user was $1.40 compared to 90c for Q2 of 2018.
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AERI | Hot Stocks06:32 EDT Aerie Pharma behins patient dosing in clinical trial of AR-13503 SR implant - Aerie Pharmaceuticals announced the commencement of patient dosing in a first-in-human clinical trial of AR-13503 Sustained Release, or SR, Implant in patients with neovascular age-related macular degeneration, or nAMD, or diabetic macular edema, or DME. This multi-arm, 24-week study is being conducted in two sequential stages. The first phase is a multicenter, open label, dose escalation study of the safety and tolerability of a single intravitreal injection of AR-13503 SR Implant, using two doses, in up to 12 patients. The second phase, enrolling up to 90 patients, is a multicenter, single-masked, randomized, parallel group study of the safety and preliminary efficacy of low- or high-dose AR-13503 SR Implant, dosed as monotherapy and in combination with aflibercept, compared to aflibercept alone. Aflibercept is a vascular endothelial growth factor, or VEGF, inhibitor approved for the treatment of retinal diseases.
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JELD | Hot Stocks06:08 EDT Steve and sons announces judge enjoined Jeld-Wen from relitigating - Steves and Sons in its antitrust litigation with JELD-WEN Holding announced Federal judge in Virginia enjoined JELD-WEN from relitigating the same claims in a San Antonio state district court that had been previously tried in Federal court in Virginia. Federal court for the Eastern District of Virginia issued a permanent injunction ending JELD-WEN's attempt to try a virtually identical lawsuit in Texas that had already been tried in his Richmond, Virginia court in which the jury, on May 11, 2018, rejected almost all of JELD-WEN's core allegations that Steves had misappropriated purported trade secrets. The jury also sided with Steves in finding that JELD-WEN had breached its long-term doorskin supply agreement with Steves. The jury awarded Steves $58M in past damages and lost profits, which the Virginia judge trebled to total $174M. Doorskins are a vital component for door manufacturing, which is Steves and Sons prime business.
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HD | Hot Stocks06:08 EDT Home Depot backs FY19 EPS view of about $10.03, consensus $10.10 - Home Depot updated its guidance for FY19, a 52-week year compared to FY18, a 53-week year. The company expects its FY19 sales to grow by approximately 2.3% and SSS for the comparable 52-week period to be up approximately 4%. The company reaffirmed its diluted EPS growth guidance for the year and expects diluted EPS growth of approximately 3.1% from FY18 to $10.03.
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ISTR | Hot Stocks06:05 EDT Investar Bank to acquire branch operations from PlainsCapital Bank - Investar Holding announced that its wholly-owned subsidiary, Investar Bank, National Association, Baton Rouge, Louisiana, entered into a Purchase and Assumption Agreement, pursuant to which Investar Bank has agreed to acquire certain assets, deposits and other liabilities relating to two existing branch locations of PlainsCapital Bank, Dallas, Texas, a wholly-owned subsidiary of Hilltop Holdings. The branches which are the subject of the Agreement are located in the Texas cities of Victoria and Alice. Under the terms of the Agreement, Investar Bank expects to acquire approximately $42M in deposits and approximately $52M in loans. In addition, Investar Bank will acquire substantially all the fixed assets at the subject branch locations, and will assume the leases for the branch facilities. The transaction is expected to close in the first quarter of 2020, subject to regulatory approvals and other customary closing conditions.
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SYBX | Hot Stocks06:02 EDT Synlogic says discontinuing development of SYNB1020 - Synlogic announced that it is discontinuing development of SYNB1020, an early stage clinical product candidate for the treatment of hyperammonemia. The decision to discontinue the program was based on top-line data from an interim analysis of a randomized, double-blind, placebo-controlled Phase 1b/2a study of the Synthetic Biotic medicine in 23 patients with cirrhosis and elevated blood ammonia. The study was designed to evaluate the safety and tolerability of SYNB1020 treatment, as well as changes in blood ammonia levels and several exploratory endpoints associated with early stage hepatic encephalopathy. SYNB1020 was well tolerated in patients with cirrhosis. Plasma and urinary nitrate increased in subjects treated with SYNB1020, indicating that the strain was active, but there was no evidence of blood ammonia lowering or changes in other exploratory endpoints relative to placebo. "We are disappointed that results from our Phase 1b/2a study of SYNB1020 did not demonstrate an activity profile in ammonia lowering that warranted continued development of the program. We would like to thank the patients and investigators who participated in the clinical trial and contributed to this research," said Aoife Brennan, M.B., B.Ch., Synlogic's president and CEO. "Moving forward, we will focus our resources on advancement of SYNB1618 for the treatment of phenylketonuria, SYNB1891 for the treatment of solid tumors and several new programs in early development." Detailed results of the Phase 1b/2a study are expected to be presented at a future scientific or medical conference.
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KBR HON | Hot Stocks05:57 EDT KBR awarded $77M contract from Honeywell Aerospace - KBR (KBR) announced today that it has won a 10-year, $77M firm fixed price, sole source contract from Honeywell Aerospace (HON) to provide logistics services for the U.S. Air Force at Hill Air Force Base Depot in Utah. KBR will support the secondary power systems for the U.S. Air Force's F-15, F-16, A-10, B-1B, B-2, C-130, and E-3 aircraft as well as their ground based auxiliary power systems. KBR will perform this work as a subcontractor to Honeywell, which won the $1.04B performance based sustainment prime contract in 2018.
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TWTR | Hot Stocks05:56 EDT Twitter says proactively suspended approx. 200,000 'spammy' accounts - In a blog post, Twitter stated: "We are disclosing a significant state-backed information operation focused on the situation in Hong Kong, specifically the protest movement and their calls for political change. ased on our intensive investigations, we have reliable evidence to support that this is a coordinated state-backed operation. Specifically, we identified large clusters of accounts behaving in a coordinated manner to amplify messages related to the Hong Kong protests. As Twitter is blocked in PRC, many of these accounts accessed Twitter using VPNs. However, some accounts accessed Twitter from specific unblocked IP addresses originating in mainland China. The accounts we are sharing today represent the most active portions of this campaign; a larger, spammy network of approximately 200,000 accounts - many created following our initial suspensions - were proactively suspended before they were substantially active on the service." Reference Link
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BDRBF | Hot Stocks05:44 EDT Bombardier confirms 3-year services contract for new East Midlands Railway - Bombardier Transportation has announced that it has signed a new Train Services Agreement, or TSA, with Abellio and Eversholt Rail for the new East Midlands Railway franchise in the United Kingdom. Under the new agreement which lasts from today until December 31, 2022, Bombardier will maintain Bombardier class 222 diesel-electric multiple unit, or DEMU, trains at Derby Etches Park depot for use on East Midlands Railway mainline services. The new agreement follows Bombardier's previous role in maintaining the 125 miles per hour trains for the former East Midlands Trains franchise. The contract is valued at approximately $161M. Under the Train Services Agreement, maintenance of the 27-strong fleet of Class 222 trains will take place at Derby Etches Park depot, where 130 staff are employed, with heavy component maintenance taking place at Bombardier Crewe.
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ELAN BAYRY | Hot Stocks05:38 EDT Elanco to acquire Bayer animal health business in deal valued at $7.6B - Elanco Animal Health (ELAN) announced it has entered into an agreement with Bayer AG (BAYRY) to acquire its animal health business in a transaction valued at $7.6B. The transaction, which is subject to regulatory approval and other customary closing conditions, "creates the second largest animal health leader while strengthening and accelerating the company's proven Innovation, Portfolio and Productivity, or IPP, strategy." The transaction will double Elanco's Companion Animal business, advancing the company's intentional portfolio mix transformation and creating a balance between its Food Animal and Companion Animal segments. Elanco expects the combined organization to continue to deliver mid-single digit revenue growth, while accelerating achievement of adjusted gross margin goals and delivering double digit adjusted EBITDA margin growth. The combination of Bayer and Elanco accelerates Elanco's margin expansion opportunity and delivers adjusted EPS accretion in the first full year post-closing, then high single to low double-digit percentage accretion in year two. The acquisition also unlocks Elanco's ability to achieve 60% adjusted gross margin and 31% adjusted EBITDA margin faster than on a stand-alone basis, with the increased ability to improve beyond. It brings operating cash flow of approximately $1B annually by the third year post-closing, allowing Elanco to reach 3x gross debt to adjusted EBITDA in the same time period, along with the potential for $275M to $300M in synergies. Finally, Elanco will bring together two complementary dedicated animal health businesses to operate on one fit-for-future infrastructure. Elanco will finance the transaction through both cash and equity. Bayer AG will receive $5.32B in cash, subject to customary purchase price adjustments, and $2.28B or approximately 68M Elanco Animal Health common shares. This represents a 70% to 30% cash-to-equity mix. Stock received by Bayer is subject to a 7.5% symmetrical collar centered on Elanco's volume-weighted average price for the 30 trading days ended August 6 of $33.60. Elanco has secured a bridge commitment for the cash portion of the consideration. It intends to fund the cash consideration through a combination of new debt and equity. At close, Elanco expects its gross debt to adjusted EBITDA leverage ratio to be ~5x, including the benefit of expected cost synergies. The strong cash flow generation profile of the combined businesses will allow Elanco to de-lever rapidly to below 3x gross debt to adjusted EBITDA by the end of 2022. The transaction is expected to close in mid-2020, subject to regulatory approvals and other customary closing conditions.
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ELAN BAYRY | Hot Stocks05:35 EDT Elanco to acquire Bayer animal health business in deal valued at $7.6B
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RDY | Hot Stocks05:22 EDT Dr. Reddy's announces U.S. launch of Vigabatrin Powder for Oral Solution - Dr. Reddy's Laboratories announced the launch of Vigabatrin Powder for Oral Solution, USP in 500 mg per packet, a therapeutic equivalent generic version of Sabril Powder for Oral Solution, USP, approved by the FDA. The Sabril brand and generic had U.S. sales of approximately $274M MAT for the most recent twelve months ending in June 2019 according to IMS Health*. Dr. Reddy's Vigabatrin Powder for Oral Solution, USP is available in 500 mg per packet in count size of 50 per carton.
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