Stockwinners Market Radar for September 09, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:59 EDT 58.com names Wei Ye as CFO - 58.com announced two key management appointments. Mr. Hao Zhou has been appointed President of International Business. In this newly created key management position. Concurrent with this appointment, Mr. Zhou will step down from his position as CFO. Mr. Wei Ye, current deputy CFO of the company, has been promoted to CFO. Mr. Zhou has served as CFO since May 2011.

19:45 EDT Mesoblast, Grunenthal enter strategic partnership for back treatment in Europe - Grunenthal announced that they have entered into a strategic partnership to develop and commercialise MPC-06-ID, a Phase III allogeneic cell therapy candidate for the treatment of chronic low back pain due to degenerative disc disease in patients who have exhausted conservative treatment options. Under the partnership, Grunenthal will have exclusive commercialisation rights to MPC-06-ID for Europe and Latin America. Mesoblast will receive up to $150M in upfront and milestone payments prior to product launch, as well as further commercialisation milestone payments. These payments include commitments up to $45M within the first year comprising $15M on signing, $20M on receiving regulatory approval to begin a confirmatory Phase III trial in Europe, and US$10 million on certain clinical and manufacturing outcomes. Cumulative milestone payments could exceed $1B depending on the final outcome of Phase III studies and patient adoption. Mesoblast will also receive tiered double digit royalties on product sales.

19:20 EDT Callon Petroleum responds to Paulso & Co filing - Callon Petroleum issued the following statement in response to the filing by Paulson & Co. Inc.: "Callon maintains an open dialogue with all of our shareholders and welcomes constructive input toward the shared goal of maximizing shareholder value. Our Board of Directors is committed to acting in the best interests of Callon shareholders and will continue to take actions to deliver returns on their behalf. The Board routinely surveys the strategic landscape and evaluates various opportunities to maximize shareholder value in the context of the prevailing operational, financial and strategic environments and remains committed to this ongoing effort. To this end, the Callon Board, with the assistance of outside financial and legal advisors, carefully evaluated the combination with Carrizo and determined that the transaction delivers compelling value to Callon shareholders." Reference Link

18:58 EDT Fly Intel: After Hours Movers - UP AFTER EARNINGS: Lakeland Industries (LAKE) up 13.5%. ALSO HIGHER: Arcada Biosciences (RKDA) up 6.7% after DE Shaw disclosed 5.5% passive stake. DOWN AFTER EARNINGS: Wendys (WEN) down 5.5% after cutting FY19 guidance... Ctrip (CTRP) down 4.6%. ALSO LOWER: Ford (F) down 3.7% after being cut to Junk at Moody's... Transalte Bio (TBIO) down 3.3% after discontinuing MRT5201 development... Cardlytics (CDLX) down 2.8% after equity offering. Movers as of 18:45ET.

18:45 EDT Alteryx CEO: We are a platform, not a point solution - In an interview on CNBC's Mad Money, CEO Dean Stoecker said: Most sports teams utilize our platform to drive a better experience for fans... We work with casinos in all parts of the world... We're very bullish on our prospects.

18:16 EDT SPDR Gold Shares holdings fall to 882.42MT from 889.75MT - This is the lowest level of holdings since August 30th.

18:00 EDT J.B. Hunt director sells 50K shares of common stock - In a regulatory filing, J.B. Hunt disclosed that its director Wayne Garrison sold 50K shares of common stock on September 6th. The total transaction size $5.56M.

17:39 EDT Suncor invess $1.4B to install cogeneration units at Oil Sands Base Plant - Suncor announced it is replacing its coke-fired boilers with two cogeneration units at its Oil Sands Base Plant. The cogeneration units will provide reliable steam generation required for Suncor's extraction and upgrading operations and generate 800 megawatts of power. The power will be transmitted to Alberta's grid, providing reliable, baseload, low-carbon power, equivalent to approximately 8% of Alberta's current electricity demand. This project will increase demand for clean natural gas from Western Canada. The project cost is estimated to be $1.4B, delivering a high teens return and projected to be in-service in the second half of 2023. This project will substantially contribute to the company's goal of an increased $2B in free funds flow by 2023. This will be achieved through Oil Sands operating cost and sustaining capital reductions along with margin improvements.

17:08 EDT Mosaic plans to initiate stock repurchases, idle phosphates operations - In advance of upcoming investor meetings, The Mosaic Company announced that it will execute several strategic actions: The company plans to initiate $250M in stock repurchases under its existing share repurchase authorization, which has $850M of remaining capacity. Effective October 1, Mosaic will idle its Louisiana phosphates operations to reduce production by approximately 500,000 tonnes in 2019. The move is expected to accelerate the reduction of high phosphate fertilizer inventories. Mosaic continues to expect strong fall fertilizer application in North America, and expects a more balanced global supply-and-demand picture to emerge by 2020. Mosaic Fertilizantes, the company's Brazil-based business unit, has implemented actions necessary to meet or exceed its previously announced synergy target of $275M in 2019. In addition, Mosaic Fertilizantes announced that it intends to drive an additional $200M in annual value through ongoing business transformation efforts by the end of 2022.

17:00 EDT Alkaline Water Company Inc trading resumes

16:53 EDT Coty exec Hughes acquires 210,000 class A common shares - In a regulatory filing, Coty Brand chief marketing officer Fiona Hughes disclosed the acquisition of 210,000 class A common shares of the company at a price of $9.806 per share.

16:37 EDT Entree Gold to voluntarily delist from NYSE - Entree Resources announces its intention to file a Form 25 with the SEC to voluntarily withdraw its common shares from listing on NYSE . The Company anticipates filing with the SEC a Form 25 on September 20, 2019 and expects the last day of trading on NYSE American to be on or about September 30, 2019. The company's shares will continue to trade on the Toronto Stock Exchange. The company has also applied to have its common shares trade on the Over-the-Counter OTCQB Venture Market and anticipates launching on the OTCQB the same date its common shares are delisted from NYSE American.

16:34 EDT Franco-Nevada promotes Paul Brink to COO, president, adds to board - Franco-Nevada announced that it continues to advance its succession planning and board renewal. Recent steps include the promotion of Paul Brink to the role of President and COO at the 2018 AGM and the addition of Jennifer Maki as a new director at the 2019 AGM. At the same meeting, Pierre Lassonde announced his intention to step down from both his Chair and director roles on the board during 2020. The board of Franco-Nevada has now made the following additional decisions:Effective as of the May 6th, 2020 AGM, the board intends to appoint David Harquail as the non-executive Chair of its board of directors. David has served as a senior executive of the original Franco-Nevada starting in 1987 and as CEO of the new Franco-Nevada since its IPO in 2007. Under his leadership, the new Franco-Nevada's market capitalization has grown to over $17B. Effective as of the May 6th, 2020 AGM, the board intends to appoint Pierre Lassonde as Chair Emeritus. Pierre and Seymour Schulich were co-founders of the original Franco-Nevada and pioneered the concept of mining royalty companies with the acquisition of the Goldstrike royalty in 1985. Pierre has served as non-executive Chair of the new Franco-Nevada since its IPO in 2007. Under his leadership, the new Franco-Nevada has had an outstanding track record of creating value for its shareholders. With Pierre's continuing role, Franco-Nevada hopes to benefit from his advice for many years to come.

16:32 EDT China Online Education announces $2M stock buyback program - China Online Education announced that its board has authorized a share repurchase program under which the company may repurchase up to $2.0M of its ordinary shares in the form of American depository shares between October 1st, 2019 and March 31st, 2020.

16:30 EDT Casey's General Stores backs FY20 guidance for same-store sales and margin - Sees FY20 Fuel SSS down 0.5% to 1.0%, Grocery/ Other Merchandise SSS up 2.5%-4.0%, and Prepared Food&Fountain SSS up 3.0%-6.0%.

16:27 EDT Americas Silver enters joint venture with Sprott to recapitalize Galena Complex - Americas Silver announced a strategic joint venture agreement with Eric Sprott to recapitalize the mining operations at the Galena Complex, located in the Silver Valley of Northwest Idaho.The strategic joint venture, expected to be 60/40 Americas/Sprott respectively, will allow Americas to increase development, modernize infrastructure, purchase new mining equipment and target exploration below current operating areas with the goal of positioning the Galena Complex to significantly increase resources, production and reduce operating costs at the mine over the next two years. Effective October 1, Sprott through 2176423 Ontario, a corporation which is beneficially owned by him, will initially commit up to $20M to fund capital improvements and operations for the first year to earn a 40% interest in the company's Galena Complex. Americas will invest an additional $5M to fund further capital improvements in 2020. After the first year of operations under the agreement, the parties will revert to their percentage ownership interests to fund capital projects and operations as required in proportion to those interests. Oversight of the joint venture will consist of two nominees from Americas and 1 nominee by Sprott. Americas will continue to manage the day-to-day operations so long as it retains an interest in the joint venture. Due to low silver prices and limited capital available from the capital markets for silver operational improvements since 2012, Americas has spent minimal funds at the Galena Complex to replace worn equipment, update aging infrastructure, stope development and exploration. Americas is currently allocating all its available capital to re-start the Relief Canyon mine in Nevada, which is scheduled to begin producing gold in late Q4. The Relief Canyon mine is targeted to increase the company's precious metal production by approximately 500% by 2021. In 2017 and 2018, the company focused available capital on developing the San Rafael mine in Mexico which this year became a significant free-cash flow generating asset. The Galena Complex possesses operational optionality and leverage to silver prices. The mine has between 1,250 and 1,500 tons of daily milling capacity though it is currently processing only 500 tons per day, five days a week. It produces between 0.8 M to 1.0 M silver ounces annually at high costs as a result of lower throughput, reduced operational flexibility and old equipment. The current proven and probable silver reserve includes 12.4M ounces, a further measured and indicated silver resource of 27.4M ounces and an inferred silver resource of approximately 39M ounces. Though this operational base is a strong starting point for comparable silver mines, a capital redevelopment of the asset is required to best exploit the existing resources, improve operational performance and capitalize on expected higher silver prices. Further, Americas and Sprott believe there are substantially more silver resources to be discovered at better grades along extensions of existing veins and at depth. Americas believes that the significant investment and joint venture announced with Sprott will allow the parties to develop the Galena Complex into a long-term, profitable mine, including to take full advantage of the recent move in silver price. Other material provisions of the agreement include standard dilution if a party does not contribute its proportionate share of costs; penalty dilution if a party defaults in contributing its share of costs; a party's interest in the joint venture is converted to a 5% net proceeds interest if that party's percentage interest falls below 10% and each party has a pre-emptive right to acquire the other party's interest should that party desire to sell its interest in the joint venture.

16:23 EDT Park West Asset Management reports 5.6% passive stake in Universal Technical - Park West Asset Management disclosed a 5.6% stake in Universal Technical, which represents about 1.44M shares. The filing does not allow for activism.

16:18 EDT Pzena Investment reports adjusted AUM as of August 31st at $36.7B

16:16 EDT SAIC awarded $60M contract from The Department of Commerce - The Department of Commerce awarded Science Applications International Corp. a systems integration contract supporting the U.S. Patent and Trademark Office. The single-award, indefinite delivery, indefinite quantity contract has a ceiling value of $60M and a five-year period of performance. Work will be performed primarily in Alexandria, Virginia, with some work offered to remote sites within the Continental United States.

16:13 EDT Mellanox exec Sultzbaugh sells 7,500 ordinary shares - In a regulatory filing, Mellanox senior VP of World Wide Sales Marc Sultzbaugh disclosed the sale of 7,500 ordinary shares of the company at a price of $109.246 per share.

16:09 EDT Translate Bio discontinues development of MRT5201, a liver-targeted treatment - Translate Bio announced that it is prioritizing the development of pulmonary disease programs including the ongoing development of MRT5005, its clinical candidate for the treatment of CF, as well as the evaluation of targets in additional pulmonary diseases. Additionally, the company has decided to discontinue the development of MRT5201, a liver-targeted treatment for OTC deficiency...The company's decision to discontinue the development of MRT5201 for OTC deficiency is based on data from recently completed preclinical studies which do not support the desired pharmacokinetic and safety profile for advancement of the program. These data are related to the first-generation lipid nanoparticle designed to be delivered to the liver via intravenous administration for the OTC deficiency program. As such, this LNP is different than that used in the CF and other pulmonary development programs which are designed to deliver the LNP-encapsulated mRNA through nebulization. Additionally, ongoing discovery efforts have generated promising, novel next-generation LNPs supporting the further development of liver disease mRNA therapeutics with potentially favorable product profiles. "We believe that the success to date in our cystic fibrosis program positions us well to build on our lung delivery platform and maximize the potential of our mRNA technology in additional pulmonary diseases with unmet medical need," said Ronald Renaud, chief executive officer, Translate Bio. "With respect to our liver disease program, our goal is an optimal product profile with patient safety as our top priority. We look forward to further data from our next-generation delivery program to support that effort."

16:07 EDT Carrols Restaurant discloses death of CFO Paul Flanders - Carrols Restaurant announced the death of Paul R. Flanders on September 7, 2019, who had served as Vice President, CFO, and Treasurer of Carrols since 1997. Mr. Flanders' duties are currently being assumed and performed by the existing finance and accounting team until his replacement is named. The Company has initiated a search for his replacement.

16:06 EDT Boyd Gaming FanDuel Group launch sports betting In Indiana, Iowa - Boyd Gaming and FanDuel Group announced the debut of FanDuel Sportsbooks at four Boyd Gaming properties: Blue Chip Casino Hotel and Spa in Michigan City, Indiana; Diamond Jo Casino in Dubuque, Iowa; Diamond Jo Casino in Northwood, Iowa; and Belterra Casino Resort in Florence, Indiana. The openings follow the successful debut of the FanDuel Sportsbook at Boyd Gaming's Valley Forge Casino Resort in King of Prussia, Pennsylvania, in March, as well as the companies' launch of mobile sports betting across the state of Pennsylvania in July. In the coming months, the two companies also plan to introduce mobile sports products under the FanDuel brand in both Iowa and Indiana, pending the receipt of required regulatory approvals.

16:05 EDT Airgain announces $7M share repurchase program - Airgain announced that its board of directors approved a share repurchase program pursuant to which Airgain may repurchase up to $7M of shares of its common stock. Under the share repurchase program, repurchases may be made from time-to-time in open market and negotiated purchases, effective immediately through the next twelve months. Airgain currently has approximately 9.7M shares outstanding.

16:04 EDT Moody's cuts Ford rating to junk, says restructuring from 'weak position' - Moody's downgraded the senior unsecured debt rating of Ford Motor Company to Ba1 from Baa3, and concurrently assigned the company a Ba1 Corporate Family Rating and an SGL-1 Speculative Grade Liquidity rating. The outlook is stable. The Ba1 ratings reflect the "considerable operating and market challenges facing Ford, and the weak earnings and cash generation likely as the company pursues a lengthy and costly restructuring plan," Moody's said in a statement. Ford's restructuring is expected to extend for "several years" with $11B in charges, and a cash cost of approximately $7B, the rating agency added. It believes Ford is undertaking this restructuring "from a weak position as measures of cash flow and profit margins are below our expectations, and below the performance of investment-grade rated auto peers." Reference Link

15:54 EDT NASH biopharma Genfit hires new Chief Medical Officer - Genfit (GNFT) announced earlier on Monday that Carol Addy has joined the company as Chief Medical Officer. Addy will drive the medical strategy of the company, including clinical development and medical affairs. Prior to joining Genfit, Addy held various leadership roles, including most recently, Chief Medical Officer at Health Management Resources, a subsidiary of Merck (MRK), and as Associate Director, Director and Senior Principal Scientist at Merck Research Laboratories.

15:34 EDT 50 AGs to probe Google over alleged antitrust practices - Attorney General Ken Paxton announced that Texas is leading 50 attorneys general in a multistate, bipartisan investigation of tech giant Google's business practices in accordance with state and federal antitrust laws. The bipartisan coalition announced plans to investigate Google's overarching control of online advertising markets and search traffic that may have led to anticompetitive behavior that harms consumers. Legal experts from each state will work in cooperation with Federal authorities to assess competitive conditions for online services and ensure that Americans have access to free digital markets. "Now, more than ever, information is power, and the most important source of information in Americans' day-to-day lives is the internet. When most Americans think of the internet, they no doubt think of Google," said Attorney General Paxton. "There is nothing wrong with a business becoming the biggest game in town if it does so through free market competition, but we have seen evidence that Google's business practices may have undermined consumer choice, stifled innovation, violated users' privacy, and put Google in control of the flow and dissemination of online information. We intend to closely follow the facts we discover in this case and proceed as necessary." Reference Link

15:30 EDT Beyond Meat competitor Impossible says launching in retail in select cities - Impossible Foods, the maker of the Impossible Burger and competitor of Beyond Meat (BYND), said in a tweet that it would be "launching in retail in select US cities this month," adding that its goal was to "make the #ImpossibleBurger available to everyone, everywhere. Stay tuned for more news to come!" Shares of Beyond Meat are lower by 4.2% in late afternoon trading. Reference Link

14:41 EDT Volkswagen unveils the ID.3 'electric car for the masses' for European market - Volkswagen said in a press release: "Volkswagen and its customers are launching into a new era of environmentally friendly mobility and will showcase the fully electric ID.3 at IAA 2019. The first model from the MEB product line for electric vehicles demonstrates a CO2-neutral balance and impresses with the high levels of driving dynamics characteristic of electric cars. It has been fully networked and, in the ID.3 1ST special edition, enables electrically powered ranges of up to 420 kilometers, WLTP,with initially three equipment variants. All ID.3 1ST models feature the most popular battery variant that provides a usable energy content of 58 kWh. The series production version will later also offer a smaller battery option with an energy content of 45 kWh and a range of up to 330 kilometers as well as a larger battery with an energy content of 77 kWh and a maximum range of 550 kilometers. Thanks to its fast charging capability, at a charging output of 100 kW it is possible to recharge the ID.3 1ST with enough energy within 30 minutes to cover a range of around 290 kilometers, WLTP-a significantly longer range than had previously been possible in the compact vehicle segment...As the basic price for the series production model will be under EURO$30,000 in Germany, the vehicle's price will be comparable to that of typical compact vehicles following the deduction of the anticipated government subsidies-an electric car for the masses. Particularly noteworthy is its unique price-range ratio that is possible solely as a result of Volkswagen's consistent strategic alignment towards electric vehicles and the associated scaling effects. The ID.3 will be delivered in Germany from mid-2020." Reference Link

14:18 EDT Citi CFO sees FICC, equities trading revenue likely to be down year-over-year - Citi CFO Mark Mason said the environment has changed since the company's investor day, but its 13.5% ROTCE target remains the same. Mason is presenting at the Barclays Global Financial Services Conference.

13:50 EDT Coty shares move higher after company announces exec changes to support growth - Earlier today, Coty announced a strengthened Leadership organization for its Supply Chain to support its ongoing turnaround plan and future growth. After the initial phase focusing on stabilizing the Supply Chain, putting in place the necessary immediate corrections with respect to our 2018 challenges which are now behind us, as well as assessing the strengths and weaknesses of this function and design the roadmap of its evolution in our turnaround plan, the time has now come to implement the action plans and focus on the key value creation objectives. Those objectives will be at the core of the refined Leadership organization for the Coty Supply Chain in which the Procurement function and Supply Operations will be organizationally disassociated and reinforced. Both will report directly to Pierre Laubies, Coty's Chief Executive Officer, and will sit at the Executive Committee. Ad interim, Procurement will be led by Gianluca Colombo - Chief Procurement Officer, and Supply Operations will be led by Jean-Claude Thomas. Pierre Laubies said: "Today's organizational changes are important steps in supporting our ongoing transformation and our strategic roadmap for future growth. Reducing complexity and costs will drive operational leadership and unlock opportunities for reinvestment and profit expansion." Following this redesign, Luc Volatier, current Chief Global Supply Officer and a member of the Executive Committee, is retiring from Coty. Pierre Laubies said: "We thank Luc and wish him the best in his future endeavours. He has made a significant contribution to Coty during his time as Chief Global Supply Officer. His leadership was important in implementing the immediate necessary corrections with respect to our 2018 supply chain challenge, and assess the actions necessary to the turnaround." Shares of Coty are up 21c or 2.15% to $10.23 per share in afternoon trading.

13:11 EDT Spotify to let users share music directly to Snapchat story - In a blog post, Spotify (SPOT) announced a new feature in conjunction with Snapchat (SNAP), where users will be able to combine both services to share what they're listening to in a Snap story. As part of a new integration, all Spotify users who have the Snapchat app installed will be able to share their favorite tracks, playlists, albums, and podcasts right to Snapchat for sharing with friends directly or posting to their Story. The integration will roll out soon across iOS and Android devices, Spotify said. Reference Link

12:27 EDT Grand Canyon falls 5% after fraud call made by Citron Research - After Citron Research called Grand Canyon its "favorite short in YEARS" and said the company is "DEAD or fraud" in a series of tweets, the stock has fallen about 5% in afternoon trading. "Low short interest stock at peak multiple whose biz just hit a secular change - forever changed while its passive holder base is blind. Will be down 70% next 18 months. CEO has lied - and customer base turns over every 2 yrs," Citron wrote in a tweet teasing its new report on the company.

12:03 EDT Air Products announces joint venture with Debang Group - Air Products announced a new joint venture with Debang Xinghua Technology, a subsidiary of Jiangsu Debang Chemical Industrial Group, to build, own and operate a coal-to-syngas processing facility in Xuwei National Petrochemical Park, Lianyungang City, Jiangsu Province, China. Air Products will own 80 percent of the JV, and Debang Group will own 20 percent. The JV will own and operate the air separation unit, gasification and purification assets under a 20-year contract for a fixed monthly fee, supplying syngas to support Debang Group's 350,000 tons-per-year chemicals facilities. The project is expected to be onstream in 2023. In addition, Air Products will be the exclusive purchaser of merchant liquid products from the JV facility, establishing a strong supply position to serve the high-growth chemical, opto-electronics and general manufacturing industries in the Lianyungang area and key surrounding cities north of Jiangsu and south of Shandong in East China.

12:01 EDT Alteryx falls -12.1% - Alteryx is down -12.1%, or -$17.19 to $124.88.

12:00 EDT Medallia falls -18.9% - Medallia is down -18.9%, or -$6.47 to $27.70.

12:00 EDT Range Resources rises 13.7% - Range Resources is up 13.7%, or 54c to $4.47.

11:50 EDT Uber announces expansion of Freight unit in Chicago - In a statement, Lior Ron, head of Uber Freight, said that, "Uber Freight will be solidifying its investment in Chicago with a new Freight headquarters at The Old Main Post Office, in Chicago's historic downtown. [...] Chicago is consistently at the forefront of innovation, from building America's foundational transportation systems and its first skyscraper, to fostering world-class universities and research centers. The city has always been at the heart of the global transportation industry, and we're eager to continue that legacy. Tapping into Chicago's rich history and incredible potential, we'll be investing $200M annually in the region, through headcount, real estate investment, and other expenses to support Uber's local operations. [...] We'll grow our team significantly, hiring thousands of new team members who are inspired by our mission to reimagine modern logistics. Specifically, Chicago will quickly become our first engineering hub outside of San Francisco, where we'll scale the team that keeps pushing our technology forward.This expansion is a testament to Uber's long-term commitment to transforming the way goods move with Uber Freight. Alongside Eats and Rides, Uber Freight is constantly looking towards the next frontier - working to redefine what's possible so that we can have the biggest impact on the people that keep our economy moving. I'm humbled by and proud of the work we've accomplished together, and I'm excited to see what opportunities Chicago unlocks for us."

11:21 EDT Dare Bio reports completion of study to support development of sildenafil cream - Dare Bioscience announced the completion of a content validity study, a non-interventional study integral to initiating the at-home, product dosing portion of the Sildenafil Cream, 3.6% Phase 2b program. Dare plans to review the findings of the content validity study with the U.S. Food and Drug Administration in a Type C meeting and to seek alignment on the patient reported outcome instruments to be used to screen eligible patients with Female Sexual Arousal Disorder and to assess the efficacy of Sildenafil Cream in treating FSAD. The content validity study was designed to demonstrate that women clinically diagnosed with FSAD can understand the items, instructions and response options of the proposed PRO instruments and to confirm that the content within the PRO instruments captures the most important and relevant symptoms of FSAD patients. Participants who met the eligibility criteria participated in one-on-one, in-depth interviews conducted by subject matter experts in the field of clinical outcome assessments and female sexual medicine. Pending alignment with the FDA, the data from this non-interventional study is intended to be used as the basis to identify and screen women with FSAD in the Phase 2b and Phase 3 studies, as well as to evaluate their response to the investigational product, Sildenafil Cream.

10:39 EDT FDA sends warning letter to Juul Labs over marketing practices - The FDA today issued a warning letter to Juul Labs for "marketing unauthorized modified risk tobacco products by engaging in labeling, advertising, and/or other activities directed to consumers, including a presentation given to youth at a school." The agency also sent a letter to the company "expressing concern, and requesting more information, about several issues raised in a recent Congressional hearing" regarding Juul's outreach and marketing practices, including those targeted at students, tribes, health insurers and employers. "These letters are the latest in a series of actions the agency has taken as part of its continued commitment to providing strong oversight of e-cigarettes and other electronic nicotine delivery systems and the latest development in the FDA's ongoing investigation related to JUUL," the agency said in a statement. Juul is 35% owned by Altria Group (MO), which has confirmed it is merger talks with Philip Morris (PM). The FDA has requested that Juul provide a written response within 15 working days describing its corrective actions and its plan for maintaining compliance with the Federal Food, Drug, and Cosmetic Act. Reference Link

10:17 EDT Vislink announces further three-year contract with Dorna Sports - Vislink Technologies announced a further three-year contract with Dorna Sports, under which Vislink remains official RF systems supplier for video communications, including onboard systems, for MotoGP, the premier motorcycle racing circuit in the world.

10:00 EDT Lannett falls -6.1% - Lannett is down -6.1%, or -80c to $12.36.

10:00 EDT Hovnanian rises 8.3% - Hovnanian is up 8.3%, or $1.05 to $13.74.

10:00 EDT Callon Petroleum rises 9.8% - Callon Petroleum is up 9.8%, or 40c to $4.48.

09:47 EDT Navios Acquisition falls -5.3% - Navios Acquisition is down -5.3%, or -35c to $6.30.

09:47 EDT Rayonier Advanced Materials falls -15.9% - Rayonier Advanced Materials is down -15.9%, or -61c to $3.23.

09:47 EDT Callon Petroleum rises 8.3% - Callon Petroleum is up 8.3%, or 34c to $4.42.

09:40 EDT Celcuity appoints Eric Lindquist as chief business officer - Celcuity (CELC) announced that Eric Lindquist joined the company as its Chief Business Officer. Prior to joining Celcuity, Lindquist was the global VP of Oncology and Rare Disease for Natera (NTRA).

09:33 EDT Wells Fargo CFO sees excess operating losses finished in about a year

09:29 EDT AT&T tells CNBC 'already executing' many of Elliott's recommended actions - In a statement to CNBC, AT&T says it looks forward to engaging with Elliott Management and that it is "already executing today" many of the actions outlined by the activist." Reference Link

09:22 EDT Green Plains completes the sale of 50% of Green Plains Cattle Company for $77M - Green Plains and a group of investment funds that include AGR Partners, StepStone Group, and several of their respective affiliates, announced that they have formed a joint venture to own and operate Green Plains Cattle Company LLC. As a part of the joint venture, these investment funds have purchased 50% of the membership interests of Green Plains Cattle Company from Green Plains Inc. for approximately $77 million plus closing adjustments. The transaction was signed on September 6, 2019 with an effective date of September 1, 2019.

09:20 EDT ServiceMaster acquires Nomor for approximately $200M - ServiceMaster announced its recent acquisition of Nomor, a Stockholm-based pest control company, with operations in Sweden and Norway. Nomor is the fourth largest pest control company in Europe. Nomor is a provider of pest control and hygiene services in both Sweden and Norway-where it operates the Pelias brand, with a head office in Elverum. The company offers a broad range of pest control and hygiene services, including preventative pest measures, food safety services, inspection and sanitation of mold/fungi and has deep relationships with the insurance industry in both countries. The company has about 500 employees and approximately 30,000 customers across Sweden and Norway. Nomor is expected to contribute approximately $60M in revenue and approximately $14M of adjusted EBITDA in FY20. The approximately $200M purchase will be funded through $120M in borrowing from the company's revolving credit facility as well as cash from operations. The current management team will stay in place. ServiceMaster acquired Nomor from Norvestor.

09:17 EDT Genmab, Tempus announce strategic collaboration - Genmab announced it has entered into a strategic collaboration agreement with Tempus, a privately-owned technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. The multi-year collaboration will combine Tempus' sequencing capabilities and industry-leading platform of integrated clinical and molecular data with Genmab's state-of-the-art translational, biomarker and target discovery expertise. The companies will work together, based upon novel insights identified by Genmab, to advance new disease targets and biomarkers that may have the potential to generate new treatments in oncology. Under the terms of the collaboration agreement, the companies will jointly work on research projects that are identified by Genmab to explore novel product concepts and biomarkers. For any resulting products, Genmab will lead all development and commercial activities. Tempus will be eligible for undisclosed milestones and royalties from Genmab and will also have the option to fund part of product development programs in exchange for increased royalty payments due to Tempus under the agreement.

09:14 EDT Enviva reports minimal impact from Hurricane Dorian - Enviva Partners reported that Hurricane Dorian has resulted in minimal impact to its operations. The Partnership undertook substantial preparation in advance of Hurricane Dorian to keep employees safe and minimize disruption, including briefly idling operations at several of our facilities directly affected by the storm. As a precaution, the North Carolina State Ports Authority ordered the closure of the Port of Wilmington late Wednesday, September 4, which suspended operations at our deep-water marine terminal there. The port re-opened early Saturday, September 7, and the Partnership immediately resumed normal operations at the Wilmington terminal. Based on initial assessments, Hurricane Dorian has not caused any material disruption in the Partnership's operations or damage to its production and terminal facilities.

09:13 EDT Blackstone appoints Vik Sawhney as Chief Administrative Officer - Blackstone announced that Vik Sawhney, Chief Operating Officer of Blackstone's private equity business, will become the firm's first Chief Administrative Officer and Global Head of Investor Relations and Business Development, effective January 1, 2020.

09:11 EDT Synopsys announces collaboration with Google Cloud - Synopsys (SNPS) announced a collaboration with Google Cloud (GOOG, GOOGL) to provide a full end-to-end solution to perform functional verification workloads in the cloud. An increasing number of users are seeking solutions that take advantage of the elastic hardware scalability offered in the cloud to address peak/burst simulation capacity requirements, enabling a higher quality verification on a predictable schedule. This collaboration provides a proven and scalable solution to enable Synopsys VCS simulation workloads on Google Cloud.

09:08 EDT HSBC standardizes on Zoom Video for enterprise communications - Zoom Video Communications (ZM) announced that HSBC (HSBC) will standardize on Zoom. With licenses available for over 290,000 users and Conference Room Connectors to over 5,500 hardware endpoints, this enterprise-wide deployment represents both Zoom's largest account sold by initial revenue and a new phase of modern communication and collaboration for HSBC. BT Group is acting as the integration partner. HSBC will consolidate all of its communications services onto Zoom's video-first unified communications platform, including video conferencing, audio conferencing, and screen sharing across mobile, desktop, and conference rooms, for both internal and external meetings. By standardizing on Zoom, HSBC will consolidate costs and create an enhanced, frictionless experience for end users.

09:06 EDT UPS to hire roughly 100,000 seasonal employees - UPS announced that it expects to hire about 100,000 seasonal employees to support the anticipated annual increase in package volume that will begin in November and continue through January 2020. The full- and part-time seasonal positions - primarily package handlers, drivers and driver-helpers - have long been an entry point for permanent employment at UPS. Many senior UPS executives, including Chairman and CEO David Abney and other members of the company's senior leadership team, started their UPS careers as part-time employees.

09:05 EDT STMicroelectronics to supply silicon-carbide power electronics to Renault-Nissan - STMicroelectronics (STM) has been chosen to supply high-efficiency silicon-carbide power electronics by Renault (RNDSF)-Nissan (NSANY)-Mitsubishi for advanced on-board chargers in its upcoming electric vehicles. Renault-Nissan-Mitsubishi plans to use the new SiC power technology to build more efficient and compact high-power OBCs that will further increase attractiveness of electric vehicles for the users by cutting battery-charging time and enhancing driving range. As Renault-Nissan-Mitsubishi's chosen partner for advanced SiC technology, ST will provide design-in support to help maximize OBC performance and reliability. ST is also to supply Renault-Nissan-Mitsubishi with associated components, including standard silicon devices. The OBCs with ST's SiC are scheduled to enter volume production in 2021.

09:03 EDT Comtech awarded additional $9.2M on Army contract - Comtech announced that its command and control technologies group received additional funding of $9.2M on a previously announced three-year $124.2M contract to provide ongoing sustainment services for the AN/TSC-198A SNAP and baseband equipment. SNAP terminals provide mobile satellite communications capabilities to personnel in the field. The contract has been funded $74.9M to date.

09:03 EDT Medtronic announces reimbursement in Germany for MiniMed 670G pump system - Medtronic announced it has secured reimbursement for the MiniMed 670G insulin pump system with the German Federal Association of the Statutory Health Insurances. The MiniMed 670G system is the only commercially available technology in the world that personalizes the delivery of basal insulin 24 hours a day based on real-time insulin needs, to maximize Time in Range for an individual living with type 1 diabetes. Time in Range is defined as the percentage of time spent in the optimal glycemic range of 70-180 mg/dL.

09:00 EDT Neurotrope trading resumes

08:56 EDT Osisko Gold announces credit bid transaction in regards to Renard Diamond mine - Osisko Gold Royalties announces that it has entered into a letter of intent with Stornoway Diamond Corporation and certain of its subsidiaries alongside other secured creditors under the bridge financing agreement entered into with Stornoway on June 10, 2019, including Diaquem Inc., a wholly-owned subsidiary of Ressources Quebec. Under the terms of the LOI, Osisko and the Secured Creditors have confirmed their intention to form an entity which will acquire by way of a credit bid transaction all or substantially all of the assets and properties of Stornoway, and assume the debts and liabilities owing to the Secured Creditors as well as the ongoing obligations relating to the operation of the Renard mine, subject to certain limited exceptions.Pursuant to the Credit Bid Transaction, Osisko will maintain its 9.6% diamond stream on the Renard mine and will continue to receive stream deliveries, and has agreed to reinvest its proceeds from the stream for a period of 1 year from the date of closing of the Credit Bid Transaction. In connection with the Credit Bid Transaction, Stornoway has applied today to the Superior Court of Quebec for protection under the Companies' Creditors Arrangement Act in order to restructure its business and financial affairs. Stornoway continues to operate during the restructuring. Concurrently with entering into the LOI, Osisko and certain of the Secured Creditors have entered into a definitive and binding working capital facility agreement with Stornoway providing for a working capital facility in an initial amount of $20 million, which facility is secured by a priority charge over the assets of Stornoway and can be increased for additional amounts at the option of the Secured Creditors. Osisko's attributable portion of the working capital facility will be approximately $7 million, of which $2.46 million is expected to be advanced today. The working capital facility provides the financing and liquidity required to ensure that the Renard mine continues to operate in an uninterrupted manner.

08:52 EDT Independence Realty Trust reports minimal damage to communities from Dorian - Independence Realty Trust announced the company's owned and managed apartment communities in Charleston, Myrtle Beach and Wilmington are operational and have not suffered any significant damage as a result of Hurricane Dorian. At this time, IRT does not expect any material impact on its residents or the company's financial performance.

08:46 EDT Mateon Therapeutics, WideTrial partner for data-generating EAP in cancer - Mateon Therapeutics announced that it has executed agreements with WideTrial Inc. for an Expanded Access program in pancreatic cancer. Using WideTrial's novel platform, the investigational therapeutic OT-101 will be made available for elective treatment-use to patients who do not meet the inclusion criteria of OT-101 research trials. The partnership may also support Expanded Access for OT-101 in additional patients with advanced solid tumors, excluding brain cancers. Separately, the companies executed data access agreements to support the development of Mateon's AI/Blockchain technologies with WideTrial's data assets in cancer and other therapeutic areas. OT-101 is a RNA therapeutic targeting TGF beta and is the lead immune-oncology drug candidate of Oncotelic, a wholly owned subsidiary of Mateon Therapeutics Inc.. The investigational drug exhibited single-agent activity in relapsed/refractory cancer patients during multiple Phase 2 clinical trials.

08:43 EDT IES Holdings announces extension of credit agreement - IES Holdings announced that it has entered into an amendment to its credit agreement with Wells Fargo Bank, National Association. The amendment extends the maturity of the credit agreement from August 9, 2021 to September 30, 2024, reduces the applicable interest rate margins across the borrowing grid, eliminates the minimum EBITDA covenant, and modifies certain other terms to provide the Company with additional flexibility. The maximum borrowing amount under the revolving credit facility established by the credit agreement remains at $100M.

08:41 EDT Scientific Games, Caesars launch sports betting in Indiana - Scientific Games (SGMS) and Caesars Entertainment (CZR) launched retail sportsbook solutions at the Indiana Grand Racing & Casino in Shelbyville, Indiana on Sept. 1. This launch marks the first venue where sports betting wagers can be taken in the state of Indiana, and the fifth state in the companies' sports betting partnership. Six more Caesars properties in Indiana are slated to launch in September, rapidly expanding the state's sports betting presence. Following the recent launches in Indiana, Iowa, Mississippi, New Jersey, and Pennsylvania earlier this year, the sports betting partnership between Scientific Games and Caesars will continue to expand into new markets with the introduction of OpenSports solutions in Illinois and North Carolina. Scientific Games will bring mobile sports betting to Caesars' Indiana properties as regulations allow, and expects to launch mobile solutions in Pennsylvania this month and in Iowa in late 2019.

08:36 EDT Cesca Therapeutics, ThermoGenesis announce distribution agreement for X-Series - Cesca Therapeutics and ThermoGenesis filed a Form 8-K last Friday with the SEC announcing the signing of an exclusive, global distribution agreement in which the company will supply its X-Series cell processing products to a leading, major life sciences distributor who will market them globally. The X-Series products are major components of the company's CAR-TXpress platform, a semi-automated, closed cellular processing platform used for high efficiency cell purification and cell washing. The X-Series products, when used in combination with the company's proprietary buoyancy activated cell sorting technology, can be applied for both research and commercial manufacturing of a large variety of cell-based therapeutics, including chimeric antigen receptor-T cells. Under the renewable, five-year agreement, the global distributor will be responsible for marketing the X-Series products to customers, worldwide, including existing X-Series customers, with the exception of China for the first two years. The company will receive a $2M upfront distribution fee, and future market support for granting the exclusive rights.

08:36 EDT InspireMD working with FDA on further testing information to secure IDE approval - InspireMD provided a business update. At the recent joint Congress of World Heart Federatio and the European Society of Cardiolog which was held August 31-September 4 in Paris, data was presented for the first time on a patient-level mesh stent metanalysis that included 556 symptomatic and asymptomatic carotid artery disease patients from four trials. Key highlights from the presentation: The results demonstrate superiority of CGuard EPS in clinical safety and efficacy as compared to competitor devices, both first generation stents and second-generation double layer or mesh covered devices. At the one-year follow-up, patients who received a competitive double layer stent or another mesh covered stent experienced an intrastent restenosis/thrombosis rate of 4% compared to CGuard EPS with a reduced incidence of 0.7%. CGuard demonstrated positive trends compared to competitors' devices with a combined endpoint at 12 months showing a 33% reduction in death and stroke and a greater than 50% reduction in overall mortality. In an earlier session, entitled "New Data in Carotid Disease: From Understanding the Pathology to Management," Professor Piotr Musialek presented four-year follow-up data from his ongoing PARADIGM-EXTEND Study. The presentation, "PARADIGM-EXTEND Prospective Academic Trial: Accumulating Long-Term Evidence for MicroNet Covered Stent Safety and Stroke Prevention Efficacy," demonstrated encouraging short- and long-term clinical results for the CGuard EPS. After 402 patients were treated with 436 stents, no major stroke occurred at 30 days and less than 1% of any death/stroke or myocardial infarction at 30 days. Additionally, Professor Musialek reported on 61 patients now followed out four years showing no device related or procedure related adverse events. InspireMD also announced that the company has been granted two new U.S. patents covering its proprietary single fiber mesh technology. The single fiber mesh, known as MicroNet, is a key differentiating feature of the company's C-Guard EPS for the prevention of stroke in patients being treated for carotid artery disease. InspireMD also announced today that it has been working closely with the FDA on providing further bench testing information to secure approval for an Investigational Device Exemption. As the company noted in its August 6th quarterly conference call with investors, seeking additional information in connection with an IDE application is not unusual. To this point, the company has interacted with the agency during the formal review period to resolve a few items and the company intends to continue to work closely with the FDA to resolve these additional requests. The FDA has concurred with the clinical study design which provides specificity on the clinical data requirements to support the market approval of the device. Following additional discussions with the FDA, the company expects to have a better sense of the timing of a formal response to the agency.

08:32 EDT Jaguar Health promotes Jonathan Wolin to chief of staff, CCO, general counsel - Jaguar Health announced that it has promoted Jonathan Wolin to the expanded role of chief of staff, chief compliance officer and general counsel. "We are thrilled to have Jon take on this important and expanded role as part of Jaguar's management team. He has a proven track record of leadership across our legal function, as well as broad business and compliance experience in the life sciences space," commented Lisa Conte, Jaguar's president and CEO. "He has served as a trusted advisor to myself, our board, and key leaders across different parts of our business at a very key time, now that we've transitioned from an R&D company into a commercial-stage human health product company with a pipeline of potential crofelemer follow-on indications as we look to build Jaguar into a global leader in the development and commercialization of novel entries into the field of gastrointestinal health." Wolin, who joined Jaguar in November of 2018, previously held the title of chief compliance officer and corporate counsel at the company.

08:31 EDT Zogenix completes acquisition of Modis Therapeutics - Zogenix, announced that it has successfully completed its acquisition of Modis Therapeutics, Inc., a privately-held biopharmaceutical company, and added MT1621 to its late-stage development pipeline. MT1621 is a novel investigational deoxynucleoside substrate enhancement therapy for the treatment of Thymidine Kinase 2 deficiency, an inherited mitochondrial DNA depletion disorder that predominantly affects children and is often fatal. At closing, Zogenix paid Modis approximately $175 million in cash, funded in full via the Company's existing balance sheet, and approximately $75 million in Zogenix common stock based on a 25-day volume weighted average price of $46.68 per share. Modis is also eligible to receive milestone payments consisting of $100 million upon U.S. Food and Drug Administration approval of MT1621 and $50 million upon European Medicines Agency approval of MT1621. Zogenix will also pay a 5% royalty on any future net sales of MT1621.

08:26 EDT Blucora to unify wealth management division as Avantax - Blucora announced that it will be rebranding its wealth management business to Avantax Wealth Management, a move designed to bring broader awareness to the company's first-of-its-kind Tax-Smart wealth management approach, providing tax-focused advice with cutting-edge tools and software. With the new brand, Blucora plans to unify its two wealth management divisions, HD Vest and 1st Global, Inc. after acquiring the latter earlier this year, which added scale and expanded its established tax-optimized financial services footprint by creating the largest, most capable tax-focused wealth management community in the country. Together, HD Vest and 1st Global have a total of 4,200 affiliated advisors, who oversee more than $67 billion in client assets. In June, the company launched a new proprietary tax-smart investing software platform, which seeks to help advisors systematically capture tax-alpha for clients. The first Tax-Smart module included at launch focused on tax-loss harvesting, with additional Tax-Smart modules slated to be added by year end. The Avantax Tax-Smart approach helps clients maximize one of life's most complicated and costly expenses: taxes. The company arms advisors with tools, processes and platforms to accurately and efficiently combine tax planning and wealth management strategies to optimize a clients' financial success. The rebranding is expected to take place in two phases, with HD Vest converting to the Avantax Wealth Management name in mid-September 2019, followed by 1st Global once regulatory approval has been obtained.

08:25 EDT Neurotrope trading halted, news pending

08:22 EDT Paulson & Co. opposes Callon's proposed acquisition of Carrizo Oil & Gas - Paulson & Co., as manager of funds holding 21.6M shares, or 9.5% of those outstanding, of Callon Petroleum (CPE), sent a letter to the board of Callon. The letter informs Callon that Paulson plans to vote its shares against the proposed acquisition of Carrizo Oil & Gas (CRZO) and urges the board and management to pursue a sale of the company. The letter outlines the reasons why Paulson opposes the proposed acquisition: "Callon's stock price has fallen by 36% since the transaction was announced. Shareholders have lost $530M in value. Callon is paying Carrizo a 25% premium, which is unjustifiable given the inferior assets of Carrizo, and results in the transfer of $240M in value from Callon shareholders to Carrizo shareholders. Callon will lose its premium valuation as a "pure play" Permian producer, resulting in multiple contraction. Based on the multiples at which pure Permian producers trade, Callon's shares could be worth 64% more than its current value through a sale of the Company. Adding Carrizo's inferior Eagle Ford assets will permanently reduce the attractiveness of Callon to potential acquirers. The sharp decline in the company's stock price since the transaction announcement on July 15 demonstrates the market's judgement of the value-eroding nature of the proposed acquisition. Holding only 0.5% of the company's shares outstanding, the board and management have not been meaningfully exposed to the value that has been lost by Callon shareholders. If the board is truly interested in its shareholders, given the magnitude of the difference between the current stock price of Callon and its takeover value, it should pursue a sale of Callon."

08:21 EDT NIC Inc. company IIC awarded 2-year contract from State of Idaho - The State of Idaho Information Technology Services has awarded Idaho Information Consortium, or IIC, an NIC company, a two-year contract with two additional one-year extension options. "The new agreement allows IIC to continue improving on previous services and to include new services based on state and local government agencies' evolving needs."

08:18 EDT Personalis enters into research agreement with Invectys - Personalis announced that it has entered into a research agreement with Invectys, a biopharmaceutical company focused on the development of innovative immunotherapy approaches to treat cancers. Under the terms of the agreement, Personalis will provide comprehensive tumor immunogenomics capabilities to facilitate biomarker discovery in chronic lymphocytic leukemia patients enrolled in a Phase II clinical trial assessing the efficacy of INVAC-1, a DNA plasmid encoding a modified human telomerase reverse transcriptase protein, as monotherapy or in combination with ibrutinib.

08:17 EDT Oncternal Therapeutics announces management appointments - Oncternal Therapeutics announced the appointment of Gunnar Kaufmann, Ph.D., as Chief Scientific Officer and Igor Bilinsky, Ph.D., as Chief Business Officer. Prior to joining Oncternal, Dr. Kaufmann served as Senior Vice President, Immunotherapy, Head of Research and Global Partnerships at Sorrento Therapeutics. Dr. Bilinsky formerly served as Chief Operating Officer of AmpliPhi Biosciences.

08:13 EDT Adaptimmune announces ODD from FDA for SPEAR T-cells targeting MAGE-A4 - Adaptimmune Therapeutics announced that the United States Food and Drug Administration has granted Orphan Drug Designation to SPEAR T-cells targeting MAGE-A4 for the treatment of soft tissue sarcomas. Orphan Designation by FDA was created to encourage the development of drugs for rare diseases, such as sarcomas.

08:10 EDT Lloyds plans additional provision for PPI, suspends 2019 buyback - Lloyds Banking Group provided an update on charges relating to the mis-selling of Payment Protection Insurance, or "PPI," stating: "At our half year results on 31 July 2019, the Group reported a PPI charge for the first half of 2019 of GBP650M, with an unutilized provision of GBP1.083B relating to complaints and associated administration costs. At that time, the Group also stated that its provision was based on the assumption that PPI information requests continued at the elevated level of around 190,000 per week until the deadline for submission of claims on 29 August 2019. In line with the broader market, the volume of PIRs received in August was higher than expected, with a significant spike in the final days before the deadline expired. In the final month the Group received approximately 600,000 to 800,000 PIRs per week, well above the previous assumption. While the quality of these complaint volumes remains uncertain, given initial sampling, we believe the quality has continued at a low level. The Group also experienced an increase in direct complaints in the same period. Including claims by the Official Receiver, the Group now estimates that it will need to make an incremental charge for PPI claims, in addition to the provisions to 30 June 2019, in the range of GBP1.2B to GBP1.8B in its Q3 Interim Management Statement. The estimated range amounts are preliminary and unaudited. The Group continues to process PIRs and the final PPI provision could be above or below the range provided. The Group now expects capital build in 2019 to be below our ongoing 170 to 200 basis points per annum guidance and for the statutory return on tangible equity to be lower than our 2019 guidance of around 12%, with the final outcome dependent on the actual charge taken. In line with its prudent approach, and the uncertainty around the final outcome for PPI, the Board has decided to suspend the remainder of the 2019 buyback program, with c.GBP600M of the up to GBP1.75B program expected to be unused at mid-September. In line with normal practice, the Board will give consideration to the distribution of surplus capital at the year end and continues to target a progressive and sustainable ordinary dividend. As previously reported, the Board's view of the level of capital required by the Group to grow the business, meet regulatory requirements and cover uncertainties reduced earlier this year from around 13% to around 12.5%, plus a management buffer of around 1%."

08:09 EDT US Antimony announces continued progress on Los Juarez gold and silver project - United States Antimony announced progress on the gold, silver, and antimony Los Juarez project. Major milestones towards production that have been completed in the last month include the installation of the HDPE pond liner in the 5 acre tailings pond, and the deepening of the water well to 222 meters to provide more than 240 gallons of water per minute. The pond and the well will be more than adequate to ramp production from 100 tons per day to 400 tons per day. Projects remaining include fencing the pond, completion of the laboratory for fire assaying precious metals, and atomic adsorption equipment for assaying antimony silver and gold in the leach circuit. The mill fine ore bin has been filled with crushed ore from the mine. Initial testing could start within 30 to 60 days. CEO John Lawrence said "As a result of lower antimony prices and increasing prices for gold and silver, USAC will prioritize precious metals. The company is now very close to the start-up, testing and shake down of the Los Juarez gold and silver leach at the Puerto Blanco mill. The company continues to take steps to reduce its costs of producing antimony products in response to the lower global sale prices."

08:08 EDT Pfizer announces preliminary results from 20vPnC Phase 2 study - Pfizer announced preliminary results following administration of three doses in a four-dose series for a proof-of-concept Phase 2 study to assess safety and immunogenicity of its 20-valent pneumococcal conjugate vaccine, or 20vPnC, candidate, PF-06482077, being investigated for the prevention of invasive disease and otitis media caused by Streptococcus pneumoniae serotypes contained in the vaccine in healthy infants. Pfizer's 20vPnC candidate includes the 13 serotypes contained in Prevnar 13 plus seven additional serotypes. B7471003 is a randomized, double-blind Phase 2 proof-of concept study to assess the safety and immunogenicity of 20vPnC in approximately 460 healthy infants. Subjects were randomized equally to receive a 4-dose series of either 20vPnC or Prevnar 13 at two, four, six and 12 months of age. Local reactions and systemic events were collected for 7 days after each vaccination. Adverse events were collected in a similar fashion to the Prevnar 13 infant program. Pfizer has completed enrollment in its three Phase 3 pivotal clinical trials evaluating 20vPnC for the prevention of invasive disease and pneumonia in adults 18 years and older. Combined, these three trials have enrolled more than 6,000 adult subjects, including populations of vaccine-naive adults and adults with prior pneumococcal vaccination. Pfizer remains on track to submit the biologics license application for the adult 20vPnC indications to the U.S. FDA by the end of 2020, subject to the successful completion of these Phase 3 studies.

08:07 EDT Aileron Therapeutics announces CFO Don Dougherty to depart - Aileron Therapeutics announced that Don Dougherty, its current CFO, will be leaving Aileron effective September 13, 2019. All financial responsibilities are being transitioned to Richard Wanstall, who has served as the Company's Vice President of Finance and Operations and principal accounting officer since 2018.

08:05 EDT PriceSmart reports August net merchandise sales up 4.5% to $259.9M - PriceSmart announced that for the month of August, net merchandise sales increased 4.5% to $259.9M, from $248.8M in August a year earlier. Foreign currency exchange rate fluctuations impacted net merchandise sales negatively by $6.5M or 2.5% versus the same prior year one-month period. There were 43 warehouse clubs in operation at the end of August and 41 warehouse clubs in operation at the end of August 2018. For the five weeks ended September 1, comparable warehouse sales for the 41 warehouse clubs open at least 13 1/2 full months increased 1.1% from the comparable five week period a year ago. Foreign currency exchange rate fluctuations impacted comparable net merchandise sales negatively by $7.3M or 2.6% versus the same prior year period.

08:02 EDT Akamai to acquire Exceda in all-cash transaction - Akamai announces that the company has entered into an agreement to acquire Exceda, its largest channel partner in Latin America. The all-cash transaction is expected to close in the fourth quarter of 2019. Akamai expects the Exceda transaction to add approximately $2M of revenue in 2019, and $15M in 2020. Further, it is expected to be 1c dilutive to its non-GAAP earnings per share for 2019, and 1c-2c accretive in 2020. The acquisition is not expected to impact Akamai's previously-stated goal of achieving a non-GAAP operating margin of 30% by 2020. Akamai is unable, without unreasonable effort, to provide guidance on the planned acquisition's impact on GAAP earnings per share and operating margin, largely because it is unable to calculate the value of the acquired intangible assets and resulting amortization at this time.

08:00 EDT First Defiance Financial trading resumes

08:00 EDT Cassava Sciences Inc trading resumes

07:49 EDT AT&T jumps over 6% after Elliott outlines plan to nearly double share price

07:47 EDT Auxly Cannabis receives cannabis oil sales licenses for Dosecann, Kolab - Auxly Cannabis Group announced that its wholly-owned subsidiaries, Dosecann and Kolab Project have both been authorized by Health Canada to sell cannabis oil under the Cannabis Regulations. The issuance of these sales licences marks a significant milestone for Auxly in furthering its strategy to deliver branded derivative cannabis products to market when such products become legal later this year. The licences enable each of Dosecann and Kolab to commence initial sales of cannabis oil products to provincial and territorial purchasers; through Kolab's flagship retail store in Saskatchewan; and to registered medical patients across the country through Kolab's online portal at kolabproject.com.

07:45 EDT Enlivex says Israeli Patent Authority issues NOA for Allocetra application - Enlivex Therapeutics announced that the Israeli Patent Authority issued a notice of allowance for a patent application covering ALLOCETRA, the company's immunotherapy product. Upon issuance, the new patent will provide added intellectual property protection, including methods, uses and pharmaceutical compositions. The company expects that this new patent will be issued in Israel during the second half of 2019.

07:44 EDT Elliott calls for 'constructive engagement' with AT&T on plan - The letter concludes by calling for constructive engagement on a mutually agreed-upon plan to realize this unique opportunity for all AT&T stakeholders.

07:43 EDT Elliott: 'Activating AT&T' plan recommends increased strategic focus

07:42 EDT First Defiance Financial to acquire United Community Financial - First Defiance Financial (FDEF) and United Community Financial (UCFC) announced the signing of a definitive merger agreement under which United Community will merge into First Defiance in a stock-for-stock transaction. Home Savings Bank, a wholly owned subsidiary of United Community, will merge into First Federal Bank of the Midwest, a wholly owned subsidiary of First Defiance. Under the terms of the merger agreement, shareholders of United Community will receive 0.3715 shares of First Defiance common stock for each share of United Community common stock. Based upon a closing price for First Defiance as of September 6 of $26.32, the transaction is valued at approximately $473M. Upon closing, First Defiance shareholders will own approximately 52.5% of the combined company and United Community shareholders will own approximately 47.5%. First Defiance and United Community believe that this strategic business combination is extremely attractive to shareholders of both companies. Both sets of shareholders will benefit from the synergies created by the transaction and the significantly increased size and scale of the pro forma company will generate efficiencies, strengthen operating leverage and further enhance shareholder value. The merger combines two complementary banking platforms, and First Defiance and United Community consider this partnership an ideal strategic, financial and operational fit, particularly given their respective strong and consistent performance over time. The pro forma combined company will have approximately $6.1B in assets, $5B in loans and $4.9B in deposits, utilizing financial information as of June 30. It will leverage the respective strengths of each institution in commercial banking, residential lending, retail, insurance and wealth management and better position the combined company to serve the geographies of Ohio, Michigan, Indiana, Pennsylvania and West Virginia with increased scale and expanded product offerings.

07:41 EDT Kaleido Biosciences, Gustave Roussy collaborate to develop MMT - Kaleido Biosciences announced plans to develop Microbiome Metabolic Therapies to enhance the effects of cancer immunotherapies under a new research collaboration with Gustave Roussy, the largest cancer treatment center in Europe. Kaleido's MMTs are designed to modulate the metabolic output and profile of the microbiome by driving the function and distribution of the organ's existing microbes. Working closely with scientists at Gustave Roussy - Professors Laurence Zitvogel, M.D., Ph.D., and Guido Kroemer, M.D., Ph.D. - Kaleido aims to identify and characterize MMT candidates with the potential to improve cancer immunotherapy efficacy by increasing the number of patients who respond to inhibitors of immune checkpoints such as CTLA-4 and PD-1/PD-L1. While checkpoint inhibitors have been effective in treating certain cancers, studies have shown that overall, the majority of cancer patients do not respond to checkpoint therapy. The collaboration is aimed at improving outcomes in patients who don't respond to checkpoint inhibitor treatment by changing their microbiome composition and metabolic output. Kaleido will employ its proprietary screening platform to analyze intestinal microbiome samples from checkpoint inhibitor non-responder patients and identify MMTs that induce changes in the microbial communities associated with favorable response to treatment. Gustave Roussy researchers will then use their advanced preclinical models to identify those compounds that stimulate the targeted therapeutic responses. Initial data obtained with these models indicate translational potential and suggest that they may serve as a critical step prior to clinical testing as well as serve as powerful tools for delineating underlying mechanisms of action.

07:39 EDT Biohaven Pharmaceutical presents expanded data from study of rimegepant - Biohaven Pharmaceutical announced that it presented expanded data and post-hoc analyses from its long term clinical study demonstrating clinically important benefits of rimegepant on migraine-specific disability and quality of life in the late breaking oral and poster sessions at the International Headache Conference in Dublin, Ireland. Over 1,700 patients with migraine enrolled in this study. Disability and quality of life outcome measures were assessed at baseline and Weeks 12, 24, 36, and 52 using the Migraine Disability Assessment and the Migraine-Specific Quality of Life Scale. Patients received rimegepant 75 mg as needed up to once daily for the acute treatment of migraine. This dose has been shown to produce statistically significant and clinically meaningful benefits in three positive phase 3 pivotal trials. These new analyses demonstrated improvements in migraine-related disability that were clinically important and statistically significant at all time points. Additionally, significant improvements in absenteeism and presenteeism items were seen throughout treatment follow-up. At baseline, the mean Total MIDAS Score was 33.8+0.8, reflecting a severely disabled level of functioning for the study population. Rimegepant demonstrated improvements in mean change from baseline for Total MIDAS Score across weeks 12 to 52: -12.5 [-13.93, -11.07] at Wk 12; -14.1 [-15.75, -12.51] at Wk 24; -14.8 [-16.59, -13.01] at Wk 36; and -14.0 [-15.93, -12.13] at Wk 52. Improvements in MIDAS scores were clinically important and statistically significant.

07:38 EDT Rhythm Pharmaceuticals to expand Phase 2 Basket Study of setmelanotide - Rhythm Pharmaceuticals announced plans to expand its Phase 2 Basket Study evaluating setmelanotide to include four additional rare melanocortin-4 receptor pathway-driven disorders. The company will host and webcast a Research & Development event to provide an update on genetic sequencing results and the Phase 2 Basket Study on Wednesday, Sept. 25. Company management will provide details on: Four new indications added to the Phase 2 Basket Study: SRC1 deficiency obesity; SH2B1 deficiency obesity; MC4R deficiency obesity; and Smith-Magenis syndrome; Yield from sequencing nearly 14,000 patients with early-onset, severe obesity for POMC, LEPR and MC4R pathway HETs obesities, as well as these four new indications; Disease prevalence and epidemiology estimates for patients with genetic variants tied to these indications based on Rhythm's sequencing data; and Patient identification efforts for Bardet-Biedl syndrome and Alstrom syndrome, two indications currently being studied in a pivotal, Phase 3 trial. Rhythm remains on track to share the full data from its Phase 3 clinical trials in Pro-opiomelanocortin deficiency obesity and Leptin receptor deficiency obesity in a forthcoming publication and in a presentation at an upcoming medical meeting.

07:35 EDT Tradeweb Markets reports August ADV up 67.9% y/y to $832.4B - Tradeweb Markets reported average daily volume, or ADV, of $832.4B in aggregate for the month of August, representing an increase of 67.9% year over year.

07:34 EDT Allergan, Molecular Partners announce FDA accepts BLA for Abicipar pegol - Allergan and Molecular Partners announced that the U.S. FDA has accepted a Biologics License Application and the European Medicines Agency has validated a Marketing Authorisation Application for Abicipar pegol, a novel, investigational DARPin therapy, in patients with neovascular age-related macular degeneration. The FDA is expected to take action on the BLA mid-2020. A decision from the European Commission is expected in the second half of 2020.

07:33 EDT Changyou.com receives buyout proposal from Sohu.com for $10.00 per ADS in cash - Changyou.com (CYOU) announced that its board of directors has received a preliminary non-binding proposal letter, dated September 9, 2019, from Sohu.com (SOHU), a Cayman Islands company and the ultimate controlling shareholder of Changyou, to acquire all of the outstanding Class A ordinary shares of Changyou, including Class A ordinary shares represented by American depositary shares, each representing two Class A ordinary shares, that are not already owned by Sohu for a purchase price of $5.00 per Class A ordinary share, or $10.00 per ADS, in cash. As Sohu holds all of the Class B ordinary shares of Changyou that are currently outstanding, the Proposed Transaction, if completed, would result in Changyou becoming a privately-held, indirect wholly-owned subsidiary of Sohu, and Changyou's ADSs would be delisted from the NASDAQ Global Select Market. The Company expects that a special committee of the Changyou Board, composed solely of independent directors, will consider the Proposal Letter and the Proposed Transaction. The company cautions that the Changyou Board has just received the Proposal Letter and has not made any decisions with respect to the Proposal Letter and the Proposed Transaction. There can be no assurance that Sohu will make any definitive offer to Changyou, that any definitive agreement relating to the Proposal Letter will be entered into between Changyou and Sohu, or that the Proposed Transaction or any other similar transaction will be approved or consummated. The company also received formal confirmation today from Dr. Charles Zhang that he is no longer pursuing his 2017 non-binding proposal to acquire Changyou himself.

07:25 EDT Wells Fargo sees FY19 NII down about 6% from FY18 - Says interest rates have continued to rally since the start of the year and our net interest income expectations have trended down throughout 2019. Compared to when it announced second quarter earnings in July, Wells says the market is pricing in lower fed funds, lower long end rates and a flatter yield curve. If rates remain within the existing range of market expectations, Wells Fargo says its current expectation is for full year 2019 NII to down ~6% from full year 2018. Current expectations are for 2H19 net interest income to be down ~$1.8B from 1H19, the bank adds. It expects Q3 mortgage originations to be up from Q2 on higher refinance volumes; Q3 production margin expected to be up from Q2 driven by higher retail margins. The bank says it is working hard to deliver on its 2019 expense target of $52B-$53B and currently expect 2019 noninterest expense to be near the high-end of the range as expense efficiencies are being offset by higher ongoing investment spend. Comments from slides being presented at the Barclays Global Financial Services Conference.

07:25 EDT United Community Financial trading halted, news pending

07:21 EDT First Commonwealth completes acquisition of 14 Santander Bank branches - First Commonwealth Financial Corporation (FCF) announced that its banking subsidiary, First Commonwealth Bank, completed the purchase of 14 central Pennsylvania retail banking locations from Santander Bank (SAN). This transaction expands First Commonwealth's presence into the markets of State College, Lock Haven, Williamsport and Lewisburg. First Commonwealth has converted the acquired branches and transitioned all customer accounts, with all 14 locations opened as First Commonwealth Bank branches with First Commonwealth signage on Monday morning, September 9, 2019.

07:17 EDT Washington Prime partners with DeBartolo-York family to design DeBartolo Commons - Washington Prime Group announced a partnership with the DeBartolo-York family to design a new four-acre athletic and entertainment green space and event venue to be named DeBartolo Commons located at Southern Park Mall. In addition to the DeBartolo-York family, Boardman Township and its park district are also partners with Washington Prime Group regarding the creation of this one-of-a-kind venue which will serve the approximately 565,000 individuals who call the Greater Youngstown MSA home. In addition, the Company announced the creation of a new entertainment hub at Southern Park Mall, which is expected to be anchored by several venues, each overlooking DeBartolo Commons: a new 37,000 SF indoor golf entertainment center and accompanying restaurant; a new entertainment venue featuring interesting food and beverage options combined with fun leisure activities; and additional new dining options. In addition to their proximity to DeBartolo Commons, these venues will benefit from their adjacency to the recently renovated Cinemark Theaters.

07:15 EDT Eldorado Gold provides updates on Kisladag, Lamaque, Greek projects - Eldorado Gold announces updates on Kisladag metallurgical testwork, its expansion plans at Lamaque and its Greek projects. Kisladag metallurgical testwork is advancing well with the majority of test results now expected to be completed prior to year-end 2019. A suite of extended Intermittent Bottle Roll Tests have been completed to help predict heap leach recovery on the existing reserve. IBRT tests are indicating that with the longer heap leach cycle of 250 days, gold recoveries are trending over 50%. More than 100 two-metre columns are also underway, which is the standard test for heap leaching, to confirm the findings of the IBRTs. The preliminary results, utilizing the IBRT metallurgical testwork, are indicating a possible mine life extension beyond the current three year guidance. In the event that testwork supports a mine life extension, waste stripping would be necessary. The company expects to be in a position to determine the most economic path for the development of Kisladag by the end of Q1 2020. The company is evaluating an expansion at its Lamaque project, which would be designed to increase throughput from an average of approximately 1,800 tonnes per day to 2,500 tpd and increase average annual production from approximately 130,000 ounces of gold to approximately 170,000 ounces of gold. Eldorado is working on a Preliminary Economic Assessment for this expansion, which will include inferred resources up to and including the C7 shear zone at the Triangle deposit, and is scheduled to be completed in Q4 2019. Subject to the results of the PEA, the company will begin a Prefeasibility Study on the Lamaque expansion, which is expected in 2H 2020. The company recently received certain installation permits for its Skouries and Olympias assets in Greece. Eldorado is working with the Greek government to achieve the necessary conditions required to re-start construction at Skouries and to allow for the completion of the development, construction and financing of the Kassandra assets.

07:11 EDT Phio Pharmaceuticals announces research collaboration with Carisma Therapeutics - Phio Pharmaceuticals announced that it has entered into a research collaboration with Carisma Therapeutics to evaluate the potential of Phio's self-delivering RNAi compounds to synergistically modify Carisma's chimeric antigen receptor macrophages. Silencing of key genes using sd-rxRNA compounds may enhance the immune function of these cells as a novel adoptive cell therapy for use in cancer treatment.

07:09 EDT Village Farms: Pure Sunfarms receives license amendment to supply cannabis - Village Farms announced that its 50%-owned joint venture for large-scale, low-cost, high-quality cannabis production, Pure Sunfarms, has received from Health Canada the amendment to its license permitting it to sell and distribute packaged, Pure Sunfarms-branded dried cannabis products directly to provincial/territorial wholesalers and authorized private retailers in accordance with provincial/territorial frameworks in Canada, effective immediately. Pure Sunfarms has supply agreements in place with the Ontario Cannabis Retail Corporation and the British Columbia Liquor Distribution Branch and expects to begin shipping Pure Sunfarms-branded products to both the OCRC and BCLDB in the coming weeks. Combined, Ontario and British Columbia comprise more than half of Canada's population.

07:08 EDT Theravance Biopharma announces 'positive' results from Phase 1 trial of TD-8236 - Theravance Biopharma announced initial results, including positive biomarker responses, from its Phase 1 single-ascending dose and multiple-ascending dose clinical trial of TD-8236, an investigational, lung-selective inhaled pan-Janus kinase inhibitor for inflammatory lung diseases. TD-8236 is specifically designed to be delivered to the lung via dry powder inhalation, targeting airway inflammation in the lung with minimal systemic exposure. Data from the study demonstrated TD-8236 to be generally well tolerated as a single dose (up to 4500 mcg) in healthy subjects and as a once-daily dose (up to 4000 mcg) given for seven consecutive days in patients with mild asthma. There was no evidence of local irritation or bronchoconstriction. There were no severe or serious adverse events reported and no subject discontinued due to adverse events. The majority of adverse events were deemed to be mild and all AEs resolved by follow-up visits. None of the AEs were considered related to TD-8236 and there were no clinically relevant changes seen in any safety laboratory measures including hematologic parameters, or in electrocardiograms or vital sign assessments. The trial also quantified the amount of TD-8236 that entered the systemic circulation following inhaled administration. These pharmacokinetic results showed that plasma levels of TD-8236 in study subjects were several orders of magnitude below the levels predicted to cause systemic pharmacological activity, which is consistent with data from preclinical studies and the organ-selective design of the compound. An additional objective of the Phase 1 program was to determine biological evidence of an anti-inflammatory effect in the lungs of asthma patients. Evidence of the biological activity of TD-8236 in the lung was demonstrated in the repeat dose portion of the study, which recruited patients with mild asthma who had elevated levels of fractional exhaled nitric oxide. FeNO is an established disease activity biomarker in asthma, and reductions in FeNO are associated with a decrease in airway inflammation. Over the seven days of TD-8236 administration once daily by inhalation, patients experienced reductions in both pre-dose and six-hour post-dose FeNO compared to placebo at all doses above 150mcg. Importantly, this included greater than10pbb reduction in pre-dose FeNO on Day 7 for all doses above 150mcg. Based on these positive study results, Theravance Biopharma has initiated a Part C extension portion of the Phase 1 trial that is designed to assess a range of additional biomarkers in patients with more severe asthma to further evaluate the potential impact of TD-8236 in the patient population most likely to benefit from this therapy. The company also intends to initiate a lung allergen challenge Phase 2 study to provide key additional insights that will inform future clinical trials of the compound.

07:05 EDT Ansys, Autodesk announce collaboration - ANSYS (ANSS) Autodesk (ADSK) announced a collaboration to help automotive companies combine visual design review and regulatory compliance validation in a connected workflow. The alliance will connect Autodesk's automotive 3D visualization and virtual prototyping software with ANSYS' physics-based lighting simulation solutions, enabling automakers to complement hyper-realistic visualizations of vehicle interiors and exteriors with highly accurate lighting simulation.

07:04 EDT Acceleron receives orphan drug designation for sotatercept from FDA - Acceleron announced that the FDA has granted orphan drug designation to sotatercept for the treatment of patients with pulmonary arterial hypertension, or PAH. Sotatercept is being evaluated in two Phase 2 trials in patients with PAH: the PULSAR trial, which completed its target enrollment in June of this year and the SPECTRA exploratory trial, which is currently enrolling. The company expects to report top-line results from the PULSAR trial during Q1 of 2020. Sotatercept is an investigational therapy that is not approved for any use in any country.

07:03 EDT Altimmune appoints M. Scott Harris as CMO - Altimmune announced it has appointed M. Scott Harris, M.D. as chief medical officer. Dr. Harris is succeeding Dr. Sybil Tasker, who resigned June 30, 2019 to continue her professional focus on infectious diseases. Previously, Harris was co-founder and CMO of Lyric Pharmaceuticals.

07:02 EDT Quanta Services acquires three companies for $330M, sees accretion - Quanta Services announced that it has completed the acquisition of Hallen Construction. Founded in 1927 and headquartered in Plainview, New York, Hallen has relationships with utilities in its markets, primarily providing gas distribution and transmission services and, to a lesser extent, underground electric distribution and transmission services. Over the past several years, Hallen has achieved organic revenue and profit growth. Additionally, Quanta recently completed the acquisition of two specialty utility foundation and pole-setting contractors serving the southeast United States. The aggregate consideration paid for these companies was approximately $330M, consisting of approximately $328M in cash, subject to working capital adjustments, and approximately $2M in stock. Based on the companies' average historical margins over the last five-years, the acquired businesses are expected to be accretive to segment margins going forward. Quanta believes the acquisition of Hallen, coupled with Quanta's existing margin enhancement initiatives, should accelerate the company's progress toward achieving its medium-term target operating income margins of upper single digits for the pipeline and industrial infrastructure services segment. Quanta estimates that these acquisitions will contribute approximately $175M of revenue in 2019 and be accretive to 2019 adjusted EPS expectations by approximately 6c. For 2020, Quanta estimates the acquired businesses will contribute revenues of $525M-$575M, modest GAAP EPS accretion due to amortization expense and adjusted EPS accretion of at least 20c. Additionally, these acquisitions are expected to be accretive to Quanta's future cash flow generation and return on invested capital. These expectations do not include any cost or growth synergies, although Quanta believes opportunities exist in the near and medium term. Final GAAP expectations are not available on a forward-looking basis because the purchase price accounting for these acquisitions has not been finalized, specifically the valuation and amortization periods of identifiable intangible assets.

07:01 EDT TreeHouse appoints Amit Philip as Chief Strategy Officer - TreeHouse Foods (THS) announced that Amit Philip has joined the company as Senior Vice President, Chief Strategy Officer. Philip was most recently Vice President of Analytics and Insights at Hershey (HSY) and managed a global team responsible for business decision analytics, consumer & shopper insights, and advanced analytics.

06:56 EDT Dollar General announces plans to expand to 46 states in 2020 - Dollar General is excited to announce it is currently under construction on new stores in Washington and Wyoming. When completed, these stores are expected to expand the company's presence to 46 states throughout the country. Stores are currently under construction in Centralia, Washington (Lewis County); Cathlamet, Washington (Wahkiakum County) and Pine Bluffs, Wyoming (Laramie County). These initial stores are scheduled to celebrate grand openings in early fiscal year 2020.

06:52 EDT WestRock to reconfigure SC paper mill, sees workforce reduction of about 260 - WestRock announced that it is reconfiguring its North Charleston, SC, paper mill to improve the mill's operating efficiency and long-term competitiveness. As part of the reconfiguration, WestRock will permanently shut down one of the mill's three paper machines and related physical infrastructure, eliminating approximately 288,000 tons of linerboard capacity. The reconfigured mill's production capacity will total approximately 605,000 tons per year, consisting of three grades: kraft linerboard; KraftPak, an unbleached folding carton kraft paper; and DuraSorb, a saturating kraft paper used for decorative laminate and industrial end uses. The company anticipates that the reconfiguration will increase WestRock's annual EBITDA by approximately $40M, primarily due to the reduction in operating costs from the shutdown of the paper machine and its associated infrastructure. This reconfiguration includes an anticipated workforce reduction of approximately 260 positions at this mill over a five-month period, starting in January 2020.

06:38 EDT Baytex Energy sees average production for 2019 of approximately 97,000 boe/d - Management said, "Strong operating performance has continued across our asset base during the third quarter. Despite the volatility in crude oil prices, we continue to drive capital efficiencies across our business, deliver stable production and meaningful free cash flow. We are now forecasting average production for 2019 of approximately 97,000 boe/d (83% oil and NGL). This compares to our original guidance range for 2019 of 93,000 to 97,000 boe/d, which was recently tightened to 96,000 to 97,000 boe/d. We expect to exit 2019 producing 95,000-97,000 boe/d. This represents debt-adjusted production per share growth of 7-9% as compared to our 2018 exit production rate. We continue to drive capital discipline and now anticipate exploration and development expenditures for 2019 of approximately $560 million. This compares to our original guidance range of $550 to $650 million, which was recently tightened to $550 to $600 million. Based on the forward strip for the balance of 2019, we expect to generate approximately $300 million of free cash flow, which supports our de-leveraging strategy."

06:33 EDT Workiva names Julie Iskow as COO, effective October 1 - Workiva (WK) announced that the company's Board of Directors has named Julie Iskow to be Executive Vice President and COO, effective October 1. Iskow will report to Marty Vanderploeg, Workiva CEO. Iskow was previously Executive Vice President and Chief Technology Officer at Medidata Solutions (MDSO).

06:31 EDT Acadia says Phase 3 HARMONY study met its primary endpoint - Acadia Pharmaceuticals announced that its Phase 3 HARMONY study, a double-blind, placebo-controlled relapse prevention trial evaluating pimavanserin for the treatment of dementia-related psychosis, met its primary endpoint, demonstrating a highly statistically significant longer time to relapse of psychosis with pimavanserin compared to placebo in a planned interim efficacy analysis. Upon the recommendation of the study's independent data monitoring committee, which met to review the data from the planned interim efficacy analysis, the study will now be stopped early based on pre-specified stopping criteria requiring a one-sided p-value less than 0.0033 on the study's primary endpoint. The company is planning to meet with the FDA regarding a supplemental NDA submission in 2020 and the results from the HARMONY study will be submitted for presentation at upcoming medical meetings. The FDA previously granted Breakthrough Therapy Designation for pimavanserin for the treatment of dementia-related psychosis. No drug is approved by the FDA for the treatment of dementia-related psychosis.

06:12 EDT Fennec names Shubh Goel as chief commercial officer - Fennec (FENC) announced that it has appointed Shubh Goel as chief commercial officer. In this newly created position, Goel will build and oversee Fennec's commercial strategy and organization, including the launch and commercialization of PEDMARK, if approved. Most recently, Goel served as Vice President of Commercial Strategy and Operations at Odonate Therapeutics (ODT).

06:08 EDT Organigram receives Health Canada's approval for additional cultivation rooms - Organigram is pleased to announce that effective September 6, it has received Health Canada's approval for the licensing of 17 additional cultivation rooms under the Cannabis Regulations. The new cultivation rooms represent approximately 15,000 kg/yr of increased target production capacity. These are the first 17 rooms licensed within the company's Phase 4B expansion and now brings the company's Moncton facility to annualized licensed capacity to a target of 76,000 kg. The licenses are valid until March 27, 2020 and subject to terms and conditions.

06:06 EDT Axonics announces FDA approval of sacral neuromodulation system - Axonics announced the approval of the Axonics r-SNM System by the United States FDA. The Axonics System is the first rechargeable SNM system approved for sale in the United States, Europe, Canada and Australia. The FDA approval grants Axonics the right to market its product in the United States for the clinical indication of fecal incontinence. The approval includes the claim of a 15-year functional life and the ability of patients to undergo full-body MRI scans without the necessity of having the device explanted. Axonics has an additional pre-market approval filing currently under review with the FDA for the clinical indications of overactive bladder as well as urinary retention for which the company anticipates a determination in the near term.

06:02 EDT Baker Hughes announces August international rig count of 1,138, down 24 - Baker Hughes (BHGE), a GE (GE) company announced that the Baker Hughes international rig count for August 2019 was 1,138, down 24 from the 1,162 counted in July 2019, and up 130 from the 1,008 counted in August 2018. The international offshore rig count for August 2019 was 244, down 11 from the 255 counted in July 2019, and up 32 from the 212 counted in August 2018. The average U.S. rig count for August 2019 was 926, down 29 from the 955 counted in July 2019, and down 124 from the 1,050 counted in August 2018. The average Canadian rig count for August 2019 was 142, up 21 from the 121 counted in July 2019, and down 78 from the 220 counted in August 2018. The worldwide rig count for August 2019 was 2,206, down 32 from the 2,238 counted in July 2019, and down 72 from the 2,278 counted in August 2018.

05:58 EDT Google confirms receipt of civil investigative demand from DOJ - Google confirmed in a regulatory filing on Friday that it has received a civil investigative demand from the DOJ requesting records related to prior antitrust investigations. "On August 30, 2019, Alphabet received a civil investigative demand from the DOJ requesting information and documents relating to our prior antitrust investigations in the United States and elsewhere. We expect to receive in the future similar investigative demands from state attorneys general. We continue to cooperate with the DOJ, federal and state regulators in the United States, and other regulators around the world."

05:43 EDT Eli Lilly presents LIBRETTO-001 clinical trial data - Eli Lilly presented data from the LIBRETTO-001 clinical trial intended to support the registration of oral selpercatinib monotherapy, also known as LOXO-292, for the treatment of RET fusion-positive non-small cell lung cancer, or NSCLC. In the registration dataset consisting of the first 105 enrolled RET fusion-positive NSCLC patients with prior platinum-based chemotherapy, selpercatinib treatment resulted in a 68 percent objective response rate, or ORR. This population was heavily pretreated, or median of three prior systemic regimens; 55 percent previously treated with an anti-PD-1/PD-L1 antibody and 48 percent previously treated with at least one multikinase inhibitor, and ORR was similar regardless of prior therapy. Up to 50% of RET fusion-positive NSCLCs can metastasize to the brain, and in the subset of patients with brain metastases in the registrational dataset, selpercatinib treatment demonstrated a CNS, or Central Nervous System, ORR of 91%. As of the data cut-off date of June 17, median duration of response, or DOR, was 20.3 months and median progression-free survival, or PFS, was 18.4 months. Since the majority of patients remain in response or progression-free as of the data cut-off date, these medians will continue to mature over time. In a safety analysis of all 531 patients enrolled to LIBRETTO-001, selpercatinib was well-tolerated, with only 9 patients discontinuing therapy due to treatment-related toxicity. The most commonly observed adverse events, regardless of attribution, were dry mouth, diarrhea, hypertension, increased liver enzymes, fatigue, constipation, and headache. These results were presented in the Presidential Symposium Session at the 2019 World Conference on Lung Cancer in Barcelona, Spain, hosted by the International Association for the Study of Lung Cancer. Selpercatinib has received breakthrough therapy designation from the FDA.

05:23 EDT BrainStorm appoints Dr. Preetam Shah as CFO - BrainStorm (BCLI) announced that Preetam Shah, Ph.D., M.B.A., has been appointed CFO effective September 6. Dr. Shah is an experienced healthcare finance professional with over 18 years of diverse leadership experience in investment banking and venture capital, healthcare financial consulting, business development, sales and marketing, and scientific research. Prior to his appointment as BrainStorm's CFO, Dr. Shah served as Director of Healthcare Investment Banking at Barclays (BCS).