Stockwinners Market Radar for September 20, 2017 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:28 EDT S&P announces changes to S&P MidCap 400, S&P SmallCap 600 indices - S&P SmallCap 600 constituent Sanderson Farms (SAFM) will replace Cabela's (CAB) in the S&P MidCap 400, and Third Point Reinsurance (TPRE) will replace Sanderson Farms in the S&P SmallCap 600 effective prior to the open on Tuesday, September 26. Bass Pro Shops is acquiring Cabela's in a deal expected to be completed on or about that date pending final conditions.

18:26 EDT North American Energy awarded two earthworks contracts for $90M - North American Energy has secured two substantial winter season earthworks jobs with a combined value of around $90M on two different oil sands mines. In addition, the company has been awarded a three year term contract, which includes a two year extension provision for potential five year total term, to provide mine support services on the Highland Valley Copper Mine in British Columbia.

17:46 EDT On The Fly: After Hours Movers - HIGHER: AMD (AMD), up 6% after CNBC reported that Tesla (TSLA) was working with AMD on self-driving car AI chip... Amphastar Pharmaceuticals (AMPH), up 2.9% after receiving FDA approval for sodium bicarbonate injection... GSE Systems (GVP), up 3.5% after acquiring Absolute Consulting, which it said will be immediately accretive to earnings. LOWER AFTER EARNINGS: Herman Miller (MLHR), down 1.1% after reporting Q1 earnings, giving Q2 guidance... Dr Pepper Snapple Group (DPS), down 0.5% after cutting FY17 EPS guidance. ALSO LOWER: Juno Therapeutics (JUNO), down 4.2% after filing to sell $225M in common stock.

17:35 EDT Oshkosh awarded $466.7M government contract modification - Oshkosh Defense, Oshkosh, Wisconsin, has been awarded a $466,773,281 modification to contract W56HZV-09-D-0159 for procurement of Family of Medium Tactical Vehicles variants based on the current A1P2 technical data package. Work locations and functions will be determined with each order, with an estimated completion date of Aug. 25, 2018. U.S. Army Contracting Command, Warren, Michigan is the contracting activity.

17:25 EDT Blue Apron jumps after meal kit competitor Plated acquired by Albertsons - Earlier today, food retailer Albertsons announced the acquisition of Plated, "a premier meal kit service." "This move advances a shared strategy to reinvent the way consumers discover, purchase, and experience food." Plated will operate as a wholly-owned subsidiary of Albertsons. The transaction is expected to close later this month pending customary approvals. Shares of Blue Apron are up 3.5% to $5.40 per share in after hours trading.

17:18 EDT Sanderson Farms to replace Cabela's in S&P 400 at open on 9/26 - Bass Pro Shops is acquiring Cabela's in a deal expected to be completed on or about that date pending final conditions.

17:11 EDT Thomas H. Lee Advisors reports 6.95% passive stake ABM

17:04 EDT Gypsum stocks jump after peer National Gypsum announces price increase - Shares of companies exposed to the gypsum wallboard sector closed higher on Wednesday after trade group Gypsum Today reported that North Carolina-based producer National Gypsum announced January 2018 price increases. Shares of USG (USG) closed up over 6% to $31.26%,Continental Building (CBPX) closed up over 5% to $25.60 and Eagle Materials (EXP) closed up almost 3% to close at $105.07.

16:34 EDT Kearny Financial declares special cash dividend of 12c per share - Kearny Financial announced that the company's board has declared a special cash dividend of 12c per share, in an effort to return excess capital to our shareholders. The special 12c dividend will be paid to stockholders on October 18 with a record date of October 4.

16:32 EDT Kindred Healthcare estimates $20M impact from Hurricanes Irma, Harvey - Kindred Healthcare announced that the company expects a one-time pretax earnings impact from Hurricanes Irma and Harvey of approximately $20M in aggregate for Q3. The company's impacted operations have substantially returned to normal and the company does not expect any significant impact on its financial results in Q4 or beyond.

16:32 EDT Ocean Rig UDW: Court gives full force and effect to schemes of arrangement - Ocean Rig UDW announced that the United States Bankruptcy Court for the Southern District of New York has issued an order granting comity and giving full force and effect in the United States to the schemes of arrangement of the company and its subsidiaries, Drill Rigs Holdings, Drillships Financing Holding, and Drillships Ocean Ventures recently sanctioned by The Grand Court of the Cayman Islands. The terms of the restructuring approved by the Cayman Court have therefore been given effect and are enforceable in the United States.The Schemes affect only financial indebtedness. Operations will continue unaffected. Trade creditors and vendors will continue to be paid in the ordinary course of business and will not be affected by any of the Schemes. Once the Restructuring Effective Date has occurred, the Scheme Companies will be substantially deleveraged through an exchange of approximately $3.7B principal amount of debt for (i) new equity of the company, (ii) approximately $288M of cash, and (iii) $450M of new secured debt. Terms used but not defined in this announcement shall have the meaning given to them in the Explanatory Statement dated 21 July.

16:29 EDT Amphastar receives FDA approval for sodium bicarbonate injection - Amphastar announced that on September 19, the FDA granted approval of the company's abbreviated new drug application, or ANDA, for sodium bicarbonate injection 8.4% in the 50 mL Luer-Jet Prefilled Syringe System. For the past 40 years, the company has sold and marketed the product under the "grandfather" exception to the FDA's Prescription Drug Wrap-Up program. Net revenues for the company's sodium bicarbonate injection for the year ended December 31 were $5.9M. The company continues to market five grandfathered products and has ANDAs pending approval for three of these products. For the year ended December 31, the company recorded net revenues of $27.6M from these unapproved products.

16:25 EDT GSE Systems acquires Absolute Consulting, immediately accretive to earnings - GSE Systems announced that it acquired Absolute Consulting, a provider of technical consulting and staffing solutions to the global nuclear power industry. During the twelve months ending December 31, Absolute Consulting generated revenue of approximately $40M, of which over 80% came from the nuclear power industry. Absolute Consulting employs roughly 200 professionals with expertise in areas such as procedure writing, engineering, technical support, project management, training, project controls, and corrective actions. GSE acquired 100% of the equity interests of Absolute Consulting for $8.75M in cash, subject to a customary post-closing working capital adjustment. The transaction closed simultaneously with the execution of a stock purchase agreement on September 20 and is expected to add more than $2M to GSE's annual Adjusted EBITDA as well as approximately $12M to GSE's backlog. The deal is expected to be immediately accretive to GSE's earnings per share, with additional accretion and growth anticipated thereafter based on identified cost and revenue synergies. For reporting purposes, Absolute Consulting will be included in GSE's Nuclear Industry Training and Consulting segment.

16:19 EDT Washington Prime sells 41 restaurants to Four Corners Property Trust - Washington Prime Group (WPG) announced that it has a signed a definitive agreement for the sale of 41 restaurant outparcels to Four Corners Property Trust (FCPT), Inc. for a purchase price of approximately $67.2M. This pricing reflects a mid-six percent capitalization rate on in-place net operating income.

16:18 EDT LPL Financial total client cash sweep balances for August up 3.7% - LPL Financial, a wholly owned subsidiary of LPL Financial Holdings, released its monthly activity report for August. Total brokerage and advisory assets served at the end of August were approximately $551B, a 0.3% increase compared to the end of July. Total Net New Assets for August were $1.1B. Total client cash sweep balances at the end of August were $28.3B, a 3.7% increase compared to July.

16:15 EDT Anadarko reaffirms production guidance - "Separately, we want to highlight and reaffirm the guidance we have previously provided for the deepwater Gulf of Mexico, DJ and Delaware basin assets," added CEO Walker. "In the deepwater GOM, we continue to expect average production rates approaching 130,000 barrels of oil per day for the full-year 2017. In the Delaware and DJ basins, we are on track to deliver our combined projected exit rate of approximately 150,000 BOPD in 2017. Our ability to continue to meet previous targets is indicative of the quality of the company's assets and the efforts of our organization to deliver strong performance, despite challenges from recent storms. Going forward, we will continue to demonstrate financial discipline with a focus on returns. Our 2018 upstream investment plan is anticipated to produce substantial free cash flow, assuming an average oil price of $50 per barrel, while total capital spending, including midstream investments, should be approximately break-even to discretionary cash flow from operations," said Walker.

16:13 EDT Anadarko targets $1B of of share repurchases prior to year-end 2017 - Speaking about the company's recent $2.5B share repurchase plan, Al Walker, Anadarko Chairman, President and CEO said, "We believe this is a very attractive use of our cash given the value of our assets and the highly accretive nature of this program. At the current share price, this represents approximately 10 percent of the company's outstanding common shares, and we will initially target $1 billion of share repurchases prior to year-end 2017."

16:11 EDT Anadarko announces $2.5B share repurchase program - Anadarko Petroleum announced its board of directors has authorized a $2.5B share-repurchase program. The authorization extends through the end of 2018, and repurchases will be made in accordance with applicable securities laws from time to time in open market or private transactions, depending on market conditions, and may be discontinued at any time.

16:11 EDT Herman Miller reports Q1 orders, backlog up 8% organically y/y

16:08 EDT FDIC approves State Bank Financial, AloStar merger transaction - State Bank Financial Corporation, the holding company for State Bank and Trust Company, announced that the Bank has received regulatory approval from the Federal Deposit Insurance Corporation for its previously announced merger transaction between the Bank and AloStar Bank of Commerce. The merger was unanimously approved by the Boards of Directors of both companies and AloStar's shareholders prior to announcing the transaction on June 15, 2017. While no assurance can be given to this effect, the company anticipates all closing conditions to be met in order to close the transaction within the next 30 days.

16:05 EDT MiMedx responds to two "deceptive short seller articles" - MiMedx Group responded to what it called "deceptive short seller articles" published earlier today. Two short seller articles, one by Viceroy Research and the other by Aurelius Value, were published on MiMedx. MiMedx CEO Parker Petit said, "The articles include several items that have virtually no basis in fact, are littered with innuendo and contain many statements that are simply not correct. This has all the markings of a concerted short seller attack by numerous entities attempting to short our stock and profit from fictitious information and innuendos. We believe that Viceroy Research and Aurelius Value are relying on misinformation from former MiMedx employees terminated for cause. (...) We have scheduled a shareholder call tomorrow, Thursday, September 21st, at 10:30 am Eastern Time to discuss various topics on the Company's extremely positive performance and trajectory for future growth. We will also address this orchestrated short seller activity and the remedies the company is seeking (...) In the meantime, the Company encourages all shareholders to review the detailed and factual press releases the Company has issued and other reports on the Company's website (...)"

16:03 EDT Aerie announces FDA Advisory Committee meeting for Rhopressa 0.02% - Aerie Pharmaceuticals announced that a meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee of the FDA has been scheduled for October 13 to review the company's New Drug Application, or NDA, for Rhopressa 0.02% for the treatment of patients with open-angle glaucoma or ocular hypertension. Aerie submitted the NDA for Rhopressa to the FDA in February, following which the FDA set a PDUFA goal date of February 28, 2018 for the completion of its review of the Rhopressa NDA.

15:05 EDT Delphi confirms autonomous driving partnership agreement with BlackBerry - Delphi Automotive (DLPH) announced it has signed a commercial partnership agreement with BlackBerry (BBRY) to provide the operating system for its autonomous driving system. Delphi and BlackBerry QNX will collaborate to bolster software performance and safety in their operating system to advance autonomous driving technology. The BlackBerry QNX OS for Safety will facilitate Delphi's proprietary Ottomatika software algorithms and middleware, to enhance performance and safety. Delphi's fully integrated automated driving solution, Centralized Sensing Localization and Planning, is scheduled to launch in 2019, the company noted.

14:30 EDT Fuel cell providers advance after natural disasters, insider buys and upgrades - Shares of companies in fuel cell power space including Ballard (BLDP), Plug Power (PLUG), FuelCell Hydrogenics (FCEL), and Hydrogenics (HYGS) are all trading higher on Thursday after a confluence of recent natural disasters. BACKUP POWER: "Fuel cells can be used as backup power for a number of organizations during natural disasters including warehouse, critical communications centers, water supply systems, and healthcare and hospital facilities," said the Department of Energy. A spate of recent hurricanes has left a path of destruction, critically damaging infrastructure in many parts of the United States as well as the Caribbean. Currently, Maria, a Category 5 storm with sustained winds of 175 mph, is now pounding Puerto Rico. A magnitude 7.1 earthquake that hit Mexico Tuesday has left hundreds dead and damage to critical buildings and hospitals. FUEL CELLS: According to an industry trade group, fuel cells are electrical generation devices that utilize a chemical reaction to unleash a fuel's latent energy. They are clean, quiet, efficient, and scalable, allowing them versatility in nearly every power application. Just last week, the U.S. Energy Department said, "The business case for fuel cells is growing. With the industry rapidly emerging as a multibillion-dollar market opportunity, the United States is taking a leadership role in technology development, manufacturing, and economic impact. A main reason for this success is the increasing investment by the private sector and business community." Markets for fuel cell technology include transportation, material handling, defense and most notably critical infrastructure. ANALYST LIKES BALLARD: After attending fuel cell provider Ballard Power Systems' investor day in New York last Thursday, FBR analyst Carter Driscoll raised his price target for Ballard to $6.00 from $3.50, saying the company's analyst day highlighted its "robust" China mobility opportunity. Ballard is the early stages of capitalizing on the use of fuel cells for vehicle electrification, and deserves to trade at a premium to peers given its technology leadership, local presence and partnerships in China and improving financial position, Driscoll tells investors in a research note partially titled "A Vastly Different Company than Two Years Ago." The analyst reiterated a Buy rating on Ballard. PLUG POWER INSIDER BUY: This past week, Plug Power chairman George McNamee disclosed in a regulatory filing that he purchased 200,000 shares of Plug stock, worth more than $426,000 in September. PRICE ACTION: Shares of fuel cell companies are higher, including Ballard Power, up over 4%, Plug Power up 10%, FuelCell up almost 4%, and Hydrogenics, up over 1%.

14:18 EDT Pharmacies drop after Leerink says Amazon talking to PBMs - After speaking with management teams of AmerisourceBergen (ABC) and Cardinal Health (CAH), Leerink analyst David Larsen said in a research note earlier today that he was surprised to hear Amazon (AMZN) "may indeed be in conversations with some middle-market PBMs now, in an effort to get into various contract arrangements." PBMs, or pharmacy benefit managers, include Express Scripts (ESRX) and UnitedHealth (UNH). Amazon likely has the ability to go after "cash paying" customers now, and while this segment of the market may be just 5%-10% of total, it can still be material, Larsen wrote. He points out that when Walgreens Boots Alliance (WBA) captured 40M prescriptions from CVS, or less than 2% of total PBM and retail scripts, the unfavorable earnings impact was significant. In order for Amazon to be licensed in 50 states, Leerink's specialist thinks it would take 18-24 months to get all of the paperwork completed. The specialist, however, believes there would be minimal impact from Amazon on the PBMs. After Axios highlighted Larsen's research note in an afternoon post on its website, shares of pharmacy owners CVS Health and Walgreens fell around 2%. Express Scripts is up 1% to $61.89 in afternoon trading.

14:10 EDT Sanofi reports 'potential breakthrough' in preclinical work on HIV antibodies - Researchers working collaboratively from Sanofi, NIAID, Harvard Medical School, The Scripps Research Institute, and the Ragon Institute of MGH, MIT and Harvard have produced genetically engineered antibodies with the highest activity and breadth of coverage yet seen against human immunodeficiency virus, or HIV-1, reported Sanofi. "Unlike natural antibodies, trispecific antibodies engage multiple targets in a single product. This approach to multi-targeting provides an opportunity to improve protection against HIV and represents a foundation for potential new treatments of cancer, immune, and infectious diseases," said Gary Nabel, Chief Scientific Officer and Senior VP of Sanofi, and lead co-author of the study published in the journal Science today. The trispecific antibodies are currently in preclinical development, and their safety and efficacy have not been fully evaluated by any regulatory authority, the company noted.

13:33 EDT JAKKS Pacific expects to sustain net loss, negative EPS for the year - JAKKS still expects to have positive EBITDA, as adjusted, for the year, although not higher than the prior year, as previously announced. Current FY consensus is 15c.

13:10 EDT John Deere recalls lawn tractors, service part transmissions due to crash hazard - John Deere notified the CPSC that it is recalling John Deere D105 lawn tractors and service part transmissions, as the transmission can fail, posing a crash hazard. About 25,000 tractors and 500 transmissions sold as service parts are affected the U.S. and, in addition, about 1,200 were sold in Canada. No incidents or injuries have been reported.

12:41 EDT Ackman calls Chipotle shares 'extremely cheap' - Bill Ackman of Pershing Square is speaking on CNBC.

12:21 EDT Ackman says ADP CEO's stake lot more levered than Pershing's - Pershing Square's Bill Ackman is speaking on CNBC.

12:18 EDT ADP board has no shareholder orientation, Ackman says - Pershing Square's Bill Ackman is speaking on CNBC.

12:14 EDT Ackman says ADP margin opportunity closer to 1,200 basis points - Pershing Square's Bill Ackman is speaking on CNBC.

12:11 EDT ADP does not want shares held by Pershing supporters, Ackman says - Pershing Square's Bill Ackman is speaking on CNBC.

12:08 EDT Ackman says ADP products are not easy enough to use - Pershing Square's Bill Ackman is speaking on CNBC.

12:01 EDT Bill Ackman says ADP has 'massively underperformed potential' - Pershing Square's Bill Ackman is speaking on CNBC.

11:44 EDT Western Digital 'disappointed' in Toshiba proposed transfer of JV interests - Western Digital (WDC) issued the following comment on Toshiba Corporation's (TOSYY) proposed transfer of its interests in its NAND flash-memory joint ventures operated with Western Digital's SanDisk subsidiaries to a consortium led by Korea-based SK Hynix and Bain Capital: "Our goal all along has been to reach a mutually beneficial outcome that addresses all issues for Toshiba and its stakeholders, and most importantly, ensures the longevity and continued success of the JVs. Throughout our ongoing dialogue with Toshiba, we have remained flexible and have submitted numerous proposals that have specifically addressed all of Toshiba's concerns. We are disappointed that Toshiba would take this action despite Western Digital's tireless efforts to reach a resolution that is in the best interests of all stakeholders. Furthermore, it is troubling that Toshiba would pursue this transaction without SanDisk's consent, as the language in the relevant JV agreements is unambiguous, and courts have entered multiple rulings in favor of protecting SanDisk's contractual rights. Toshiba has also acknowledged and validated SanDisk's legitimate consent rights on multiple occasions." Western Digital added that it remains confident that SanDisk will succeed on the merits of its arbitration requests filed on May 14, 2017, and July 5, 2017, and those cases continue to move forward in the ICC International Court of Arbitration. In addition, on July 28, 2017, the Superior Court of California for the County of San Francisco entered a stipulated order preventing Toshiba from closing any transfer of its JV interests without providing at least 14 days advance notice to SanDisk, the company noted.

11:42 EDT Western Digital 'confident' in merits of arbitration requests against Toshiba

11:35 EDT Layne Christensen seeing increased activity in the minerals business

11:28 EDT Layne Christensen says municipal spending on pipe maintenance steady - Says there is momentum in the water space and the company is in the middle of it.

11:20 EDT trivago chairman Khosrowshahi resigns from board - In a regulatory filing, trivago (TRVG) disclosed that on September 15, the company received the resignation of Dara Khosrowshahi as member and chairman of the company's Supervisory Board. On September 18, the company's Supervisory Board approved such resignation, and elected Mark Okerstrom, President and Chief Executive Officer of Expedia (EXPE), to replace Khosrowshahi as chairman of the Supervisory Board. In addition, Robert Dzielak, Executive Vice President, General Counsel and Secretary of Expedia, has been designated as temporary member of the Supervisory Board, pending his appointment by the company's general meeting of shareholders next year. Upon his appointment as temporary member of the Supervisory Board, Dzielak will have all powers and responsibilities of a Supervisory Board member, as if he had been appointed by the general meeting of shareholders.

11:05 EDT Natera selected circulating tumor DNA study in bladder cancer - Natera has entered into a research collaboration with Denmark's Aarhus University to leverage the company's Signatera personalized liquid biopsy technology to evaluate circulating tumor DNA as a useful biomarker in the diagnosis and treatment of bladder cancer. Signatera was recently launched for research use only for oncology researchers and biopharmaceutical companies, and is not for use in diagnostic procedures. It is expected to be available for clinical use next year. The study will evaluate over 400 prospectively obtained plasma samples from patients who underwent treatment for bladder cancer, and whose blood was collected serially through chemotherapy and surgery. Sequencing data from each patient's tumor will be provided by Aarhus University and run through the Signatera proprietary ctDNA bioinformatics pipeline, resulting in custom ctDNA assays being designed for each patient. Personalized ctDNA analysis will be performed at multiple time points per patient to correlate ctDNA levels with clinical outcomes.

10:57 EDT FCA US recalling 47,927 minivans in the U.S. to realign seat-belt buckles - FCA US LLC is voluntarily recalling an estimated 47,927 minivans in the U.S. to realign certain seat-belt buckles. During testing, it was observed that an outboard seat-belt buckle in the second row could become inadvertently unlatched when the vehicle is subjected to extreme handling maneuvers. This occurred when the buckle's release button contacted that of an adjacent occupant's buckle. FCA US is unaware of any related injuries, accidents, warranty claims or complaints. Affected customers will be advised when service becomes available. Until then, they are urged to avoid using the second-row center seat in conjunction with the other second-row positions. The recall is limited to vehicles equipped with optional eight-passenger seating. Affected are certain 2017 and 2018 Chrysler Pacifica minivans.

10:44 EDT Toymakers in focus after Toys"R"Us files for bankruptcy, Amazon could benefit - Shares of toymakers, including Mattel (MAT) and Hasbro (HAS), are in focus on Tuesday morning following news that Toys"R"Us has filed for bankruptcy protection ahead of the critical holiday season. TOYS"R"US BANKRUPTCY: Toy retailer Toys"R"Us, which was acquired by private equity firms KKR (KKR) and Bain as well as real estate firm Vornado (VNO) over a decade ago and has struggled in recent years to compete with Amazon (AMZN) and Wal-Mart (WMT), officially filed for Chapter 11 bankruptcy on Monday night in federal court in Richmond, Virginia. The company said it has received a commitment for over $3B in debtor-in-possession financing from various lenders, including a JPMorgan (JPM)-led bank syndicate and certain of the company's existing lenders, which, subject to court approval, is expected to immediately improve the company's financial health and support its ongoing operations during the court-supervised process, the retailer said. Toys"R"Us said it is committed to working with its vendors "to help ensure that inventory levels are maintained and products continue to be delivered in a timely fashion." With its bankruptcy filing, Toys"R"Us becomes another casualty of the fast-changing retail industry, joining children's clothing retailer Gymboree and Payless ShoeSource. RETAILERS MOST EXPOSED: Jefferies analyst Stephanie Wissink noted earlier this month that the top three retailers most exposed to Toys"R"Us are Mattel, Hasbro and JAKKS Pacific (JAKK). Toys"R"Us made up 11%, 9%, 15%, of Hasbro, Mattel and JAKKS revenue in 2016, respectively, Wissink told clients. In a research note on Tuesday, Wissink said that the bankruptcy is "likely to create some dislocation among the vendor roster," and that companies like Hasbro and JAKKS are "strongly positioned" to maintain their financials and pursue brand consolidation opportunities. "We do not expect the bankruptcy event to trigger a domino effect in toy retail, implying massive discounting systemwide that pressures vendor margins on a sustained basis," Wissink added. TRU FILING 'POSITIVE' FOR AMAZON, WAL-MART: Separately, KeyBanc analyst Edward Yruma said this morning that the Toys"R"Us bankruptcy filing is likely to be "positive" for both Amazon and Wal-Mart, noting that baby and toy have been "strategic" categories for Amazon for years and that Wal-Mart should gain market share in the consolidating market. PRICE ACTION: In morning trading, shares of Mattel are up 0.13% to $15.07, JAKKS is up 2.65% to $2.90, and Hasbro is down 0.47% to $94.54.

10:42 EDT Office Depot says David Bleisch joins as Chief Legal Officer - Office Depot (ODP) announced N. David Bleisch, a distinguished law professional with more than 30 years of experience, has joined the company as EVP, Chief Legal Officer and Corporate Secretary. Bleisch will lead the strategic direction of the legal organization and operations, as well as manage the regulatory and compliance matters for the company. He will report directly to Office Depot's CEO Gerry Smith. Bleisch is filling the role vacated by Steve Calkins who was promoted to President, Business Solutions Division in May. Prior to joining Office Depot, Bleisch was SVP and Chief Legal Officer for The ADT Corporation (ADT).

10:34 EDT Pfizer takes J&J to court as analysts shake up pharma ratings - Morgan Stanley analyst David Risinger upgraded Pfizer (PFE) this morning to Overweight, a Buy-equivalent rating, as he believes investors underappreciate the global prospects for breast cancer drug Ibrance. Meanwhile, his peer at Goldman Sacks cut Johnson & Johnson (JNJ) to Sell as he sees more downside relative to peers. Also being announced today is news that Pfizer is currently suing Johnson & Johnson for anticompetitive practices. BUY PFIZER: In a research note to investors, Morgan Stanley's Risinger upgraded Pfizer to Overweight from Equal Weight saying that following underperformance, the company shares are poised to outperform given the global rollout of its "number one growth driver", Ibrance. The analyst pointed out that he believes Ibrance is underappreciated given peers' limitations. Competitor Novartis' (NVS) Kisqali initial launch in recent months has been slow due to requirements for cardiac and liver function monitoring, and competitor Eli Lilly (LLY) disclosed abemaciclib first-line data on September 10 indicating elevated diarrhea and blood clot risk, he noted. He also cites the stock's favorable risk-reward, and M&A optionality, especially with the prospect of U.S. tax reform. Risinger raised his price target on Pfizer shares to $39 from $35. SELL JOHNSON & JOHNSON: Meanwhile, Goldman Sachs analyst Jami Rubin downgraded Johnson & Johnson to Sell, while raising his price target on the shares to $130 from $125. The analyst told investors in a research note of his own that while pharma has improved and he expects accelerated growth in the near-term, pressure on key products coupled with still-slow Medical Devices & Diagnostics growth and persistent pressure in consumer leaves J&J with a below-average, long-term growth outlook that suggests valuation is stretched. Further, Rubin noted that he believes Johnson & Johnson's lack of optionality for value creation - high value pipeline assets, transformative M&A and operating leverage - relative to peers, challenges the sustainability of its outperformance. He prefers names like AbbVie (ABBV), Bristol-Myers Squibb (BMY) and Eli Lilly with more identifiable, needle moving catalysts. PFIZER SUIT AGAINST JNJ: Pfizer has filed suit in the U.S. District Court for the Eastern District of Pennsylvania against Johnson & Johnson. The suit alleges that Johnson & Johnson's exclusionary contracts and other anticompetitive practices have denied U.S. patients access to therapeutic options and undermined the benefits of robust price competition in the innovative and growing biologics marketplace for patients. It further claims that Johnson & Johnson's systematic efforts to maintain its monopoly in connection with Remicade by inappropriately excluding biosimilar competitors violates federal antitrust laws and undermines the principal goals of the federal Biologics Price Competition and Innovation Act. WHAT'S NOTABLE: Morgan Stanley's Risinger also downgraded Allergan (AGN) to Equal Weight from Overweight this morning. PRICE ACTION: In morning trading, shares of Pfizer have gained over 1% to $35.96, while Johnson & Johnson has dropped more than 1% to $133.41.

09:59 EDT Honeywell to provide cryogenic gas processing plant to Cureton Midstream - Honeywell announced that its UOP Russell business will provide a turn-key cryogenic gas processing plant to Cureton Midstream. The new plant is designed to extract 99% of ethane and 100% of propane from natural gas in Weld County, Colorado, located in the Niobrara basin. The UOP Russell solution includes supply and installation of modular cryogenic, dehydration, acid gas removal, residue compression, control system, flare system and site electrical equipment, in addition to site utility systems and buildings for office, control room, motor control center, and compressor requirements. The turn-key plant design streamlines project schedules and delivers a custom, gas-specific plant with proven uptime and reliability, built on the experience of nearly 130 previous cryogenic units.

09:44 EDT MiMedx accused of channel stuffing in short report from Aurelius - Aurelius Value, in a report published to its website, accused MiMedx of "large undiscounted channel stuffing" and "undisclosed related party transactions and entanglements with distributors." Reference Link

09:37 EDT Perry Ellis: J. David Scheiner to succeed George Feldenkreis as chairman - Perry Ellis International announced that its Board of Directors has elected J. David Scheiner as Non-Executive Chairman. Scheiner succeeds George Feldenkreis, following the termination of Feldenkreis' position as Executive Chairman. George Feldenkreis remains a member of the Board of Directors. These changes, which are part of a multi-year leadership succession planning process, are effective immediately. Oscar Feldenkreis will remain in his position of CEO.

09:33 EDT Pershing sends letter to ADP seeking answers to 'unanswered questions' - Pershing Square Capital Management published a letter to shareholders highlighting the significant opportunity for improvement at ADP. Pershing says, "Since our first presentation on August 17, 2017, ADP has yet to respond to the substance of our arguments and it has effectively stated that it can't do any better. Today, Pershing Square published the first in a series of weekly public questions to ADP to help investors understand whether ADP is achieving its full potential. Pershing Square asks that ADP answer these questions publicly and in a timely manner so that all investors may better evaluate the company's performance and future prospects. What are ADP's margins in Employer Services by sub-segment, excluding float and allocating corporate expenses? Is ADP earning comparable margins to Paychex in its SMB business? If so, that would imply 12% margins for the rest of Employer Services. Before shareholders cast their votes in the upcoming election, they deserve to know the margins of each sub-segment of Employer Services as these are critical data points for investors to use to evaluate the company's performance."

09:26 EDT Atwood Oceanics announces contract extension for Atwood Orca - Atwood Oceanics announced that one of its subsidiaries has agreed to a four month extension on the jackup rig Atwood Orca with Mubadala Petroleum for drilling operations offshore Thailand. The new contract is at an undisclosed day rate that is higher than the current day rate, and it includes two four-month options that are priced at successively higher day rates than the new firm day rate. As a result of this contract, the expected earliest availability of the Atwood Orca is August 2018, assuming no options are exercised. If both options were to be exercised, the drilling program would be expected to extend until approximately April 2019.

09:24 EDT General Mills says expects neutral to positive pricing in retail market in FY18

09:15 EDT Interpace Diagnostics regains compliance with audit committee requirements - Interpace Diagnostics Group announced that on September 18, 2017, the company received a letter from The Nasdaq Stock Market LLC stating that the company has regained compliance, which requires the company to maintain three audit committee members on its Board of Directors. Jack E. Stover, President and CEO of Interpace Diagnostics, stated, "We are pleased that the company has regained compliance with all NASDAQ listing requirements and can continue to transform itself for growth."

09:14 EDT Bojangles adds Robert Hull, Jr. to board, increasing size of board to 11 - Bojangles' announced the appointment of Robert F. Hull, Jr. to the Board of Directors, effective yesterday. The Board of Directors now consists of eleven members, up from ten members previously. Hull is currently the CEO and Founder of Integrity Strategic Solutions, an advisory services company.

09:13 EDT Pfizer files suit against Johnson & Johnson - Pfizer (PFE) filed suit in the U.S. District Court for the Eastern District of Pennsylvania against Johnson & Johnson (JNJ). The suit alleges that J&J's exclusionary contracts and other anticompetitive practices have denied U.S. patients access to therapeutic options and undermined the benefits of robust price competition in the innovative and growing biologics marketplace for patients. It further claims that J&J's systematic efforts to maintain its monopoly in connection with Remicade by inappropriately excluding biosimilar competitors violates federal antitrust laws and undermines the principal goals of the federal Biologics Price Competition and Innovation Act. The U.S. biosimilars marketplace is at a relatively early stage of development compared to other countries such as those in Europe. Since Congress passed the BPCIA, which became law in 2010, three biosimilars approved by the U.S. Food and Drug Administration have been launched. A biosimilar to J&J's Remicade, Inflectra was launched by Pfizer in the U.S. in late 2016 as the first biosimilar monoclonal antibody. The complaint describes how insurers originally classified Inflectra at parity with Remicade - meaning, there was no medical reason to favor Remicade over Inflectra. However, insurers reversed course after J&J threatened to withhold significant rebates unless insurers agreed to "biosimilar-exclusion" contracts that effectively block coverage for Inflectra and other infliximab biosimilars. In the absence of such coverage, providers - who depend on reimbursement from insurers - are reluctant to stock biosimilars, even to service Medicare and Medicaid patients where there is widespread coverage for Inflectra. Additionally, J&J offered providers anticompetitive contracts conditioned on the providers not purchasing biosimilars to Remicade in exchange for discounts on Remicade. These anticompetitive practices are preventing physicians from trying and patients from accessing the biosimilar.

09:12 EDT General Mills says has seen 'really good growth' in e-commerce sales

09:09 EDT Forest City sells Madison International 51% interest in NYC retail portfolio - Forest City and Madison International Realty signed definitive agreements for Madison's acquisition of Forest City's 51% interest in a 2.1-million-square-foot, 12-asset, specialty retail portfolio located throughout Manhattan, Brooklyn, Queens, the Bronx, Staten Island and Northern New Jersey, for a gross value of approximately $1.0B. Final closing is expected in Q4.

09:06 EDT Jaguar Health's Canalevia qualifies as 'minor use' for EID in dogs - Jaguar Health announced that the U.S. Food & Drug Administration's Center for Veterinary Medicine has indicated that the use of Canalevia for treatment of exercise-induced diarrhea in dogs qualifies as a "minor use", per the requirements of The Minor Use and Minor Species Animal Health Act of 2004, which means that Canalevia is eligible for conditional approval for the indication of EID in dogs. Canalevia, Jaguar's lead veterinary drug product candidate, is under investigation for treatment of various types of diarrhea in dogs. EID is a distinct physiological manifestation that has been recorded in dogs, humans and horses. Jaguar has already received MUMS designation for Canalevia for use in dogs with chemotherapy-induced diarrhea, which provides a possible opportunity to shorten the timeframe to commercialization for the CID indication. If Canalevia receives conditional approval for CID and EID in dogs, Jaguar expects to conduct the commercial launch of Canalevia for both indications in the first half of 2018.

09:04 EDT Scientific Games to acquire NYX Gaming Group for C$2.40 per share - Scientific Games and NYX Gaming Group announced that they have entered into a definitive agreement under which Scientific Games will acquire NYX, further strengthening Scientific Games' leadership position and ability to provide the broadest portfolio of content, technologies and digital products and services for its global Gaming and Lottery customers. Under the terms of the transaction, Scientific Games will acquire all of the outstanding ordinary shares of NYX for C$2.40 per share, equivalent to an enterprise value of approximately C$775M, or approximately $631M. The transaction will be financed with cash on hand and debt. It represents a 112% premium to NYX's closing stock price on September 19, 2017; and the transaction is expected to be accretive to earnings and cash flow in the first year and leverage neutral at closing. The Arrangement Agreement contains customary deal protections in favor of Scientific Games, including a termination fee payable by NYX in certain circumstances.

09:02 EDT Rent-A-Center says August results 'slightly' impacted by Hurricane Harvey

09:02 EDT Rent-A-Center reports core U.S. SSS down 5.3% in August - Rent-A-Center, announced the following preliminary key operating metrics for its Core U.S. and Acceptance NOW businesses for August 2017: Core U.S.: Same Store Sales: (5.3%); Delinquencies: 7.2%, 30 basis points favorable versus prior month, 310 basis points favorable versus prior year; Average Monthly Rate of New Agreements: 13.0% favorable versus prior year; Co-worker Turnover: 87.9% and 21.5 percentage points favorable versus prior year. Acceptance NOW: Same Store Sales: 8.6%; Delinquencies: 10.3%, 130 basis points unfavorable versus prior month, 190 basis points unfavorable versus prior year. In the Core U.S. segment, August same store sales improved sequentially by another 40 basis points, and since December 2016 the comp has improved by 740 basis points. The primary driver of the improvement to date has been the consistent execution of improved account management processes and the subsequent impact on the amount of revenue collected. The company's top line results for August were slightly impacted by Hurricane Harvey given the business disruption in the coastal Texas markets. The company is assessing damage and impact and expects to have more information at its next quarterly earnings call.

08:42 EDT General Mills says expects FY18 tax rate 'in-line' with FY17 - Sees FY18 tax rate approximately 29%.

08:38 EDT Celadon Group closing its truck driving academy - Celadon Trucking will exit its three Celadon Driving Academy locations in Indianapolis, Laredo and Richmond later this year. One of Celadon's third-party driving school partners plans to establish accredited driving schools at each of the three locations. Celadon has determined that a third-party model is a more effective way to hire new drivers.

08:33 EDT Meet Group to acquire social dating app LOVOO for $70M in cash - The Meet Group announced it has executed a definitive agreement to acquire LOVOO, a social dating app, for $70M in cash, inclusive of a $5M contingent earn-out. This acquisition furthers The Meet Group's strategy to innovate, acquire, and build the largest mobile portfolio of brands for meeting new people. The LOVOO acquisition is expected to expand The Meet Group's global footprint, increase the company's scale and profitability, and diversify its business model by adding expertise in subscription and in-app purchasing. The acquisition is expected to be accretive to the company's non-GAAP EPS in 2018 and beyond. The company expects that LOVOO will remain a separate brand and standalone mobile application following the closing of the acquisition, and that LOVOO's headquarters will remain in Dresden, Germany. The Company has extended offers to all of LOVOO's 97 full time employees. LOVOO's Co-Founder and CEO Benjamin Bak has agreed to assist with the transition for six months after closing. Effective upon closing, Florian Braunschweig, current COO and Co-Founder, has agreed to take over leadership of LOVOO as the new General Manager and Managing Director. The rest of the LOVOO management team is expected to remain in place.

08:22 EDT Lipocine announces FDA advisory committee meeting for Tlando - Lipocine announced that the Bone, Reproductive and Urologic Drugs Advisory Committee of the FDA plans to discuss the New Drug Application submitted by the company for Tlando, its oral testosterone product candidate for the proposed indication of testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. The advisory committee meeting date has not been finalized but will occur prior to the Prescription Drug User Fee Act goal date of February 8, 2018. BRUDAC reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in the practice of obstetrics, gynecology and related specialties, and makes appropriate recommendations to the Commissioner of the FDA.

08:18 EDT Altimmune opens enrollment for Phase 2 flu vaccine trial - Altimmune announced that they have been cleared by the FDA to initiate their Phase 2 clinical study of NasoVAX, the company's intranasally administered recombinant flu vaccine. NasoVAX is a new type of influenza vaccine that uses intranasal administration to potentially stimulate a broader and more rapid immune response than currently approved flu vaccines.

08:15 EDT Umpqua Holdings names Dave Shotwell Chief Risk Officer - Umpqua Holdings has named Dave Shotwell Umpqua Bank's first chief risk officer. In this new position, Shotwell will retain his role as chief credit officer. In addition to continuing to oversee the company's credit administration, Shotwell will assume responsibility for its enterprise risk management program, including data governance, compliance and information security. Shotwell has 35 years of diversified banking experience including 15 years with Umpqua Bank, where he has served as chief credit officer since 2015.

08:13 EDT XBiotech announces agreement with Cedars-Sinai Medical Center - XBiotech announced its agreement with Cedars-Sinai Medical Center located in Los Angeles, California, whereby XBiotech will provide its interleukin-1 alpha antagonist, MABp1, for a Phase I single arm study evaluating the maximum tolerated dose of Onivyde and 5-fluorouracil/folinic acid in combination with MABp1 in a cohort of patients with advanced pancreatic adenocarcinoma and cachexia. The study will also assess efficacy using various secondary measures including changes in lean body mass, weight stability, IL-6 levels, overall and progression free survival as well as evaluation of the relationship between treatment tolerance and patient functional status. Andrew Hendifar, M.D., Medical Oncology lead for the Gastrointestinal Disease Research Group at Cedars-Sinai and Co-Director of Pancreas Oncology, will be leading the study which is planned to enroll a total of 16 patients at the Cedars-Sinai Medical Center. Onivyde will be given intravenously with MABp1 and 5-fluorouracil/folinic acid every two weeks until disease progression.

08:04 EDT Fire at Valero refinery in Port Arthur extinguished with no reported injuries - A spokesperson for Valero told The Fly last night that "At approximately 11:50 am on September 19, a fire in a heavy oil tank occurred at the Valero Port Arthur Refinery. Valero emergency crews along with the Port Arthur Fire Department responded to the fire. The fire was contained and has been extinguished with no reported injuries and all personnel accounted for. The City of Port Arthur lifted the precautionary shelter-in-place around 2 pm Central Time. Air monitoring conducted by EPA and TCEQ both confirmed there was no negative off-site community impact. We appreciate the support of the City of Port Arthur, and will continue to cooperate with agencies."

08:04 EDT bluebird bio appoints Mary Lynne Headly to board of directors - bluebird bio (BLUE) announced that it has appointed Mary Lynne Hedley to its Board of Directors. Hedley co-founded TESARO (TSRO) in 2010 and since that time, has served as the company's president and as a member of its board of directors. bluebird bio also announced that with Hedley's appointment, John Maraganore will transition off the Board of Directors.

08:02 EDT Bank of Marin names James Kimball as EVP, COO, effective October 16 - Bank of Marin Bancorp, parent company of Bank of Marin (BMRC), announced that James S. Kimball will be joining the Bank as an EVP in the newly created position of COO, effective October 16. As COO, Kimball will have responsibility for the management of the Bank's lines of business, including Commercial Banking, Retail Banking, Wealth Management & Trust and Marketing. Kimball has more than 28 years of commercial banking experience and joins Bank of Marin from Wells Fargo Bank (WFC), where he most recently served as SVP and Region Head for the North Coast Regional Commercial Banking Office and Wine Industry Specialty Group.

07:41 EDT Merus awarded two new patents for Biclonics - Merus announced that it has added to its deep intellectual property portfolio two new U.S. patents related to its proprietary Biclonics technology for developing novel bispecific antibodies. On September 19, the United States Patent Office granted U.S. Patent No. 9,765,133, entitled "Antibody Producing Non-Human Mammal", which marks a first U.S. patent covering a transgenic mouse having a common light chain, related to Merus' MeMo mouse technology. Using MeMo, a leading antibody-generating platform, Merus is able to produce large and diverse panels of high affinity common light chain antibodies against a broad variety of targets, which can then be used to make high quality bispecific antibodies referred to as Biclonics. On August 22, the USPTO also granted U.S. Patent No. 9,738,701 entitled, "Method for selecting a single cell expressing a heterogeneous combination of antibodies," which relates to downstream host cells capable of effectively manufacturing Biclonics.

07:34 EDT KemPharm files IND application with FDA for KP484 for treatment of ADHD - KemPharm announced that it has filed an Investigational New Drug, or IND, application with the FDA to begin human clinical trials of KP484, the Company's prodrug product candidate of "super-extended" release d-methylphenidate, or d-MPH, for the treatment of attention deficit hyperactivity disorder, or ADHD.

07:24 EDT Ionis drops after Alnylam study meets all endpoints - Shares of Ionis Pharmaceuticals (IONS) are moving lower after Alnylam Pharmaceuticals (ALNY) and Sanofi (SNY) announced the Apollo Phase 3 study of patisiran, an investigational RNAi therapeutic being developed for patients with hereditary ATTR amyloidosis with polyneuropathy, met its primary efficacy endpoint and all secondary endpoints. Ionis in May announced today that iots Phase 3 study of inotersen in patients with familial amyloid polyneuropathy met both primary endpoints. Shares of Ionis in premarket trading are down 9%, or $5.07, to $54.00.

07:18 EDT Regenxbio completes dosing of first cohort in Phase I clinical trial of RGX-314 - Regenxbio announced that the first cohort of six patients has been dosed in a Phase I clinical trial evaluating RGX-314 for patients with wet age-related macular degeneration, or wet AMD.

07:12 EDT AVEO Oncology, EUSA Pharma announce TiNivo combination study opt-in - AVEO Oncology (AVEO) and EUSA Pharma announced that EUSA Pharma, under its multi-territory licensing agreement with AVEO for FOTIVDA, has opted into the Phase 1/2 TiNivo study. Under terms of the agreement, EUSA may utilize data from the study for regulatory or commercial purposes in exchange for a research and development funding payment totaling $2M. EUSA's decision follows approval in August of tivozanib by the European Commission for the treatment of adult patients with advanced renal cell carcinoma in the European Union plus Norway and Iceland. The TiNivo trial is a Phase 1/2 trial of tivozanib in combination with Bristol-Myers Squibb's (BMY) OPDIVO, an immune checkpoint, or PD-1, inhibitor, for the treatment of RCC. The TiNivo trial is being led by the Institut Gustave Roussy in Paris under the direction of Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee. In June, AVEO announced the advancement of the trial into the Phase 2 expansion portion following successful completion of the Phase 1 dose escalation portion. The combination was well tolerated to the full dose and schedule of single agent tivozanib, with no dose limiting toxicities. The expansion portion of the trial is expected to enroll an additional 20 subjects. Phase 1 results from the ongoing study have been submitted for presentation at a scientific meeting taking place in the fourth quarter. Under the terms of their December 2015 agreement, EUSA Pharma has agreed to pay AVEO up to $388M in future milestone payments and research and development funding, assuming successful achievement of specified development, regulatory and commercialization objectives. In addition, a tiered royalty will be due to AVEO ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the agreement's territories. With European approval, AVEO will be eligible for up to $12M in milestones from EUSA based on reimbursement and regulatory approvals. In the territories licensed to EUSA, 30% of milestone and royalty payments received by AVEO, excluding research and development payments such as the one announced today, are due to Kyowa Hakko Kirin as a sublicensing fee. In the territories retained by AVEO, the royalty obligation to KHK ranges from the low- to mid-teens on net sales.

07:07 EDT Karyopharm: 'successful' outcome from Phase 2 portion of Phase 2/3 SEAL study - Karyopharm reported a successful outcome from the Phase 2 portion of the SEAL study evaluating the activity of selinexor, the company's lead, novel, oral Selective Inhibitor of Nuclear Export / SINE compound, in 57 patients with previously treated, advanced unresectable dedifferentiated liposarcoma. For the SEAL study's primary endpoint of progression-free survival, or PFS, oral selinexor showed superiority over placebo, achieving a hazard ratio, or HR, of 0.60, representing a 40% reduction in the risk of progression or death. PFS was assessed by Independent Central Radiological Review, or ICRR, based on RECIST v1.1. In this randomized, blinded Phase 2 portion of the study, oral selinexor demonstrated an expected and manageable safety profile, primarily with nausea, anorexia and fatigue, low levels of Grade 3/4 cytopenias, and no new or unexpected safety signals identified. The majority of treatment-related adverse events, or AEs, were low grade and reversible with dose modifications and/or standard supportive care. Importantly, the incidence of infections in the selinexor arm was less than that reported in the placebo arm. Additional efficacy assessments included PFS by World Health Organization, or WHO, response criteria, effects on metabolic parameters via PET Scans, and PFS according to Choi Criteria. PFS per WHO criteria achieved a HR of 0.84; the WHO response criteria will not be included as part of the Phase 3 study objectives. Karyopharm intends to submit detailed results from the Phase 2 portion of the SEAL study for presentation at a future medical meeting.

07:05 EDT Sanofi and Alnylam report topline results of patisiran in ATTR amyloidosis - Sanofi's (SNY) specialty care global business unit,Sanofi Genzyme, and Alnylam (ALNY) announced that the APOLLO Phase 3 study of patisiran, an investigational RNAi therapeutic being developed for patients with hereditary ATTR amyloidosis with polyneuropathy, met its primary efficacy endpoint and all secondary endpoints. The primary endpoint for the study was the change from baseline in the modified neuropathy impairment score at 18 months. The key secondary endpoint was improvement in quality of life. The APOLLO trial enrolled 225 hATTR amyloidosis patients with polyneuropathy. The overall safety profile of patisiran was "encouraging". Based on these positive results, Alnylam expects to file its first New Drug Application in late 2017 and first Marketing Authorisation Application shortly thereafter. Sanofi Genzyme is currently preparing for regulatory filings for patisiran in Japan, Brazil and other countries, to begin in 1H18. Pending regulatory approvals, Alnylam will commercialize patisiran in the U.S., Canada and Western Europe, with Sanofi Genzyme commercializing the product in the rest of the world.

07:03 EDT Six Flags says no expected material impact from Mexico earthquake - Six Flags Entertainment Corporation noting yesterday's serious earthquake near Mexico City, provides this update about the company's two parks in Mexico. "Most importantly, Six Flags is thankful that all of its employees in Mexico appear to be safe and sound. Six Flags Mexico and Six Flags Hurricane Harbor Oaxtepec were closed at the time of the earthquake. The earthquake struck in the State of Puebla, south of Mexico City, which is about 50 miles from the company's new water park in Oaxtepec. A preliminary investigation indicates damage to a number of the structures in the water park and the company is currently assessing the extent of the damage. After a careful evaluation, the company will be in a better position to understand the extent of the damage, develop a remediation plan and assess when the park will reopen. Damage to the theme park in Mexico City appears to be minimal. However, consistent with its emphasis on safety for guests and employees, the company is in the process of evaluating all rides and structures in the park and will only reopen the park for guests when the company is entirely satisfied after a thorough safety review. The company maintains both property and business interruption insurance, and does not currently believe the consequences of the earthquake will be material to its results or prospects. Six Flags extends heartfelt thoughts and prayers to its employees and to all those impacted by the earthquake," the company said.

07:03 EDT General Mills reports Q1 gross margin down 150 bps to 34.8% - Gross margin decreased 150 basis points to 34.8 percent of net sales. Adjusted gross margin, which excludes certain items affecting comparability, decreased 230 basis points to 35.1 percent, driven by higher input costs including currency-driven inflation on imported products, deleverage, and unfavorable trade expense phasing.

06:54 EDT NovaBay receives noncompliance notification from NYSE - NovaBay Pharmaceuticals received a letter from NYSE American stating that it is not in compliance with continued listing standards requiring stockholders' equity of $4.0M or more if the company has reported losses from continuing operations and/or net losses in three of the four most recent fiscal years. The company was previously notified by NYSE American on May 16 that the company was not in compliance with the continued listing standard requiring stockholders' equity of $6.0M or more if the company has reported losses from continuing operation and/or net losses in its five most recent fiscal years. NovaBay submitted a plan of compliance on June 15 addressing how it intends to regain compliance by May 16, 2018. On June 29, the company was notified by NYSE American that the company's plan to regain compliance was accepted subject to periodic review by NYSE American. If the company is not in compliance by May 16, 2018, or if the company does not make progress consistent with the plan during the period, the NYSE Regulation staff may initiate delisting proceedings.

06:52 EDT Baxalta treatment of hemophilia A granted FDA orphan designation - Baxalta's treatment of hemophilia A was granted FDA orphan designation, according to a post to the agency's website. Reference Link

06:25 EDT YouTube's sponsorships now open to all YouTube Gaming creators - YouTube says in its Creator blog, "Starting today, we're opening up a new way to earn extra money on your channel and better help you connect with your fans on YouTube Gaming: sponsorships! With sponsorships, fans can purchase digital goods directly from your channel and support you via monthly recurring payments of $4.99. Sponsors get cool insider perks, such as a custom badge for live chat that will help them stand out from the crowd and custom emoji. These badges and emoji are designed by you for your fans. As you gain more sponsors, you will unlock more emoji to be used on your channel. You can upload and use these in real-time as you pass sponsorship milestones... Throughout our early tests of YouTube Gaming sponsorships, we've seen some incredible successes. Between all the trials, raids, and meteor strikes, the gaming community on YouTube continues to grow. We're excited to see how your creativity with sponsorships can help you both build stronger communities and bigger businesses." Reference Link

06:03 EDT Soligenix announces $1.5M NIDCR SBIR grant award supporting SGX942 Phase 3 trial - Soligenix announced that the National Institute of Dental and Craniofacial Research, or NIDCR, part of the National Institutes of Health, or NIH, has awarded Soligenix a Small Business Innovation Research, or SBIR, grant of approximately $1.5M over two years to support the conduct of its Phase 3, multinational, randomized, double-blind, placebo-controlled study evaluating SGX942 as a treatment for severe oral mucositis in patients with head and neck cancer receiving chemoradiation therapy.

06:00 EDT Hitachi announces launch of Hitachi Vantara digital company - Hitachi yesterday launched Hitachi Vantara, a new business entity to leverage the broad portfolio of innovation, development and experience from across Hitachi Group companies to deliver data-driven solutions for commercial and industrial enterprises. This new company will unify the operations of Hitachi Data Systems, Hitachi Insight Group, and Pentaho into a single integrated business as Hitachi Vantara to capitalize on Hitachi's social innovation capability in both operational technologies and information technologies. Hitachi Vantara will continue to provide infrastructure and analytics technologies that enterprises rely on for their mission-critical data in their data centers, in the cloud and at the edge of new innovations. The new company is targeting the emerging IoT market opportunity. The company will focus on serving global Fortune 1000 companies with best-in-class data management, infrastructure, content and analytics products and industrial IoT solutions for a number of industries including financial services and insurance, government, industrials/manufacturing, telecom, and transportation.

05:55 EDT DelMar Pharmaceuticals issued new patent for VAL-083 - DelMar Pharmaceuticals announced that the U.S. Patent and Trademark Office has issued to DelMar, United States Patent No. 9,759,698 covering improved analytical methods for analyzing and determining impurities in dianhydrogalactitol. DelMar's new patent strengthens the company's control over the VAL-083 manufacturing process and related controls. DelMar is establishing broad new intellectual property protection around VAL-083, a first-in-class DNA targeting agent that demonstrated clinical activity against a range of tumor-types in prior clinical trials sponsored by the U.S. National Cancer Institute, or NCI. VAL-083 is currently protected by eight U.S. patents and eight patents outside of the U.S., with issued claims providing patent protection into 2033 in the United States. DelMar has made patent filings under 14 separate patent families encompassing more than 100 individual patent applications.

05:49 EDT Innoviva, GSK report 'positive' headline results from IMPACT study - GlaxoSmithKline (GSK) and Innoviva (INVA) announced positive headline results from the landmark phase III IMPACT study of Trelegy Ellipta, the first and only FDA approved once-daily single inhaler triple therapy comprising an inhaled corticosteroid, or ICS, long-acting muscarinic antagonist, or LAMA, and long-acting beta agonist, or LABA. Trelegy Ellipta is approved for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease, or COPD, who are receiving Breo and require additional bronchodilation or who are receiving Breo and Incruse. The IMPACT study, which involved 10,355 patients, met its primary endpoint demonstrating statistically significant reductions in the annual rate of on-treatment moderate/severe exacerbations for FF/UMEC/VI when compared with two, once-daily dual COPD therapies from GSK's existing portfolio.

05:42 EDT Walmart to offer more hours to workers during holidays in lieu of seasonal hires - Judith McKenna, COO, Walmart U.S. released the following statement regarding the traditional hiring of seasonal employees during the holidays: "The holidays are a special time of year for our customers and associates and also one of the busiest. To help customers save time and money this season, we are offering the extra hours available this time of year to our current associates rather than hiring thousands of seasonal workers. These extra hours will help staff traditional roles like cashier and stocker, and newly created technology-empowered positions such as personal shoppers and Pickup associates. This is the same approach we took last year, and we heard great feedback from our customers and associates. This is what working in retail is all about, and we know our associates have the passion to do even more this year. We've increased our focus on service through new training, tools and technology. Thousands of associates have completed training in our Pathways and Academy programs, which prepares them to more effectively serve customers, especially during this busy season. We are also bringing back the very popular Holiday Helper and increasing the number of Helpers we have in stores this season. These associates are dedicated to helping customers get through the stores faster by finding the shortest checkout line, opening registers as needed and will even quickly grab items customers might have forgotten. Our associates make the holidays come to life in our stores, and we are thankful for everything they do to help our customers have the best possible shopping experience. As we head into our busiest time of the year, we know associates are ready to deliver for our customers and help give them a memorable and affordable Christmas."