Stockwinners Market Radar for September 12, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:04 EDT Fly Intel: After Hours Movers - HIGHER: Celsius Holdings (CELH) up 4.2% after disclosing stock purchase by chairman... Park Hotels (PK) up 3.8% after entering S&P MidCap 400 index... ViewRay (VRAY) up 3.4% after announcing collaboration with Stanford Health Care... MDC Holdings (MDC) up 1.5% after QTD Q3 net new order activity rose 63%. DOWN AFTER EARNINGS: Broadcom (AVGO) down 1.4%... Park City Group (PCYG) down 15.0%. ALSO LOWER: Ritter Pharma (RTTR) down 74.9% after its phase 3 trial of RP-G28 fails to demonstrate statistical significance... Energy Recovery (ERII) down 11.5% after filing mixed shelf, selling stock for holders. Movers as of 18:45ET

18:24 EDT Copa Holdings reports August traffic down 3.0%, capacity down 5.0% - August Load factor was up 1.8pts to 85.3%.

18:03 EDT S&P announces changes to S&P MidCap 400, S&P SmallCap 600 indices - Park Hotels & Resorts (PK) will replace Inogen (INGN) in the S&P MidCap 400 and Inogen will replace Chesapeake Lodging Trust (CHSP) in the S&P SmallCap 600 effective prior to the open of trading on Wednesday, September 18. Park Hotels & Resorts is acquiring Chesapeake Lodging Trust in a transaction expected to be completed on or about that date pending final conditions. Inogen has a market capitalization that is more representative of the small-cap market space.

17:45 EDT Air Lease EVP Levy sells 10K shares of common stock - In a regulatory filing, Air Lease disclosed that its EVP Grant Levy sold 10K shares of common stock on September 12th. The total transaction size was $447K.

17:43 EDT Fibrocell Science to be acquired by Castle Creek Pharma for $63.3M - Fibrocell Science has reached an agreement to be acquired by Castle Creek Pharmaceutical for a total consideration of approximately $63.3M, including repayment of debt and other financial instruments, in cash. Fibrocell common stockholders will receive all-cash consideration of $3.00 per share. This offer represents a 63% premium to Fibrocell's 30-day volume weighted average price as of September 11. The transaction was approved by the Boards of Directors of both companies and is expected to close in Q4. Upon completion of the transaction, Fibrocell will become a privately held subsidiary of Castle Creek Pharmaceutical. Fibrocell's employees will continue as employees of the combined company on completion of the transaction. Until that time, Fibrocell will continue to operate as a separate and independent company.

17:32 EDT Cemex to invest in GoFor to improve building material delivery, terms not stated - CEMEX Ventures announced its investment in GoFor Industries, a last-mile logistics marketplace for on-demand delivery of building materials and equipment for the home improvement and construction industries. GoFor Industries, a startup with operations in Canada and the United States, matches the delivery requirements of distributors, retailers, and contractors with lightweight to heavy-duty vehicles of its driver community inventory.

17:23 EDT Maxim Integrated VP Vivek Jain sells over $628K in company shares - Maxim Integrated VP Vivek Jain disclosed in a filing that he had sold 10,852 shares of company stock at an average price of $ $57.92 per share on September 10. The total transaction value of the sale was $628,504.

17:18 EDT Inogen to replace Chesapeake Lodging in S&P 600 at open on 9/18

17:06 EDT Wolverine World Wide names Chris Hufnamger as President of Merrell brand - Wolverine World Wide announced the appointment of Chris Hufnagel as Global Brand President of Merrell, the largest brand within its portfolio. A 10-year veteran of Wolverine, Hufnagel most recently served as Global Brand President of Cat Footwear. In his new role, Hufnagel will continue reporting to Todd Spaletto, President of the Wolverine Michigan Group. Hufnagel replaces Sue Rechner, who is leaving the company.

17:01 EDT APS issues RPFs for solar and wind energy resources - Arizona Public Service Co. issued two separate Requests for Proposals for solar and wind resources. These RFPs were first announced in late July and will help expand the company's renewable energy portfolio to approximately 2,500 megawatts by 2021 - enough to power more than half a million Arizona homes. The first RFP is seeking competitive proposals for up to 150 megawatts of APS-owned solar resources to be in service by Dec. 31, 2021. Projects must employ commercially proven technology and must be designed with the flexibility to add energy storage as a future option. The second RFP will pursue up to 250 megawatts of wind resources to be in service as soon as possible, but no later than 2022. The company will consider both APS-owned resources, as well as those owned by third parties that would sell the output to APS under a power purchase agreement. APS is the principal subsidiary of Pinnacle West.

16:50 EDT YRC Worldwide reports Q3 quarter-to-date LTL tonnage per day down 3.3% - YRC Worldwide reported certain operating metrics for the first two months of Q3. At YRC Freight, July 2019 less-than-truckload, or LTL, tonnage per day decreased approximately 3.3% compared to July 2018 and August 2019 LTL tonnage per day decreased approximately 3.6% compared to August 2018. Quarter-to-date through August 2019, LTL revenue per hundredweight and LTL revenue per shipment increased approximately 1.6% and 0.8%, respectively, compared to a year ago. At the Regional segment, July 2019 LTL tonnage per day decreased approximately 1.5% compared to July 2018 and August 2019 LTL tonnage per day decreased approximately 4.4% compared to August 2018. Quarter-to-date through August 2019, LTL revenue per hundredweight decreased approximately 0.4% compared to a year ago. LTL revenue per shipment remained flat when compared to last year.

16:47 EDT Ritter drops 72% after announcing Phase 3 trial does not meet primary endpoint - Ritter Pharmaceuticals, which was halted ahead of its announcement that its Phase 3 clinical trial of RP-G28 for lactose intolerance failed to demonstrate statistical significance in its pre-specified primary endpoint, has resumed trading and is down 72% to 30c per share in the after-hours session.

16:33 EDT Celgene announces phase 3 study results of CC-486 in newly diagnosed AML - Celgene announced top-line results from the international phase 3, randomized, double-blind, placebo-controlled study, QUAZAR AML-001. The study evaluated the efficacy and safety of investigational therapy CC-486 as maintenance therapy in patients with newly diagnosed acute myeloid leukemia, or AML, who achieved first complete response or complete response with incomplete blood count recovery with induction chemotherapy. The study demonstrated that maintenance treatment with CC-486 resulted in a highly statistically significant and clinically meaningful improvement in overall survival compared to placebo. The key secondary endpoint of relapse-free survival also showed a statistically significant improvement. CC-486 was well-tolerated and there were no unexpected safety events in QUAZAR AML-001. This phase 3 study enrolled 472 patients, randomized 1:1 to receive either oral CC-486 300mg or placebo once daily for 14 days of a 28-day cycle plus best supportive care until disease relapse. Data from QUAZAR AML-001 will be submitted to a future medical meeting. Celgene also plans regulatory submissions for CC-486 beginning in the first half of 2020.

16:20 EDT Broadcom reports Q3 adjusted gross margin 71% vs. 72% last quarter - Compared to 67.3% a year ago.

16:18 EDT Ritter Phase 3 trial of RP-G28 fails to demonstrate statistical significance - Ritter Pharmaceuticals announced that its Phase 3 clinical trial of RP-G28 for lactose intolerance failed to demonstrate statistical significance in its pre-specified primary endpoint. Top-line data from the 557-subject Phase 3 clinical trial indicates that RP-G28 provided significant symptom improvement in patients; however, there was no or little difference compared to placebo. The remaining secondary endpoints also missed statistical significance differences with treatment and placebo generally reporting similar results to each other. RP-G28 was generally well-tolerated, with placebo and treatment groups reporting similar safety profiles. "We are deeply disappointed in the results of the phase 3 clinical trial," said Ritter CEO Andrew Ritter. "We believe the clinical trial was well-designed and executed. We are continuing to analyze the results of the trial to better understand the data and clinical outcomes to assess a path forward, which may include alternative strategic options for the company."

16:16 EDT Broadcom sees FY19 adjusted operating margin 52.5%

16:12 EDT Saia set to open three new terminals, relocate terminal - Saia announced that three new Saia LTL Freight terminals will open in Erie, Pennsylvania and Buffalo and Albany, New York. The facilities in Erie and near Buffalo will open this September 16. The third terminal, near Albany, is scheduled to open September 30. Saia will relocate its Philadelphia, Pennsylvania terminal to a larger facility on September 20.

16:10 EDT Contango gets commitment for credit facility, to acquire assets of Will Energy - Contango Oil & Gas announced that the company has received a commitment from JPMorgan, Royal Bank of Canada and Cadence Bank, N.A. to provide a senior secured reserve-based revolving credit facility of up to $500M, which is expected to replace the current credit facility which matures on October 1. The initial borrowing base under the New Credit Facility is expected to be $65M. Additionally, if the Pending Acquisition is consummated on or prior to November 30, 2019, then, subject to certain conditions, the borrowing base is expected to increase to $80 million. The New Credit Facility will have a five year term. The New Credit Facility will be guaranteed by certain of the Company's subsidiaries and secured by substantially all of Contango's assets and the assets of the guarantors thereunder, including not less than 85% of the total value of the Company's proved oil and gas properties. The commitment letter provides that the New Credit Facility is subject to certain conditions to closing, including negotiation of customary credit documents in form and substance satisfactory to the lenders. Contango also announced that it has entered into a contribution and purchase agreement with Will Energy Corporation to acquire approximately 159,872 net acres located in North Louisiana and the Western Anadarko Basin in Western Oklahoma and the Texas Panhandle for aggregate consideration of $23 million, consisting of $20 million in cash and $3 million in common stock.

16:07 EDT ViewRay launches collaboration with Stanford Health Care - ViewRay announced that Stanford Health Care in Stanford, California, will acquire a MRIdian, an MR-guided radiation therapy system. MRIdian integrates MRI technology, radiation delivery, and proprietary software to locate, target, and track soft-tissue and tumors. These capabilities allow MRIdian to deliver accurate doses of radiation to the tumor while protecting nearby healthy tissues and vulnerable structures. Stanford Health Care is an academic medical center providing state-of-the-art technologies and treatments to help advance care and improve outcomes for patients.

16:06 EDT Manning & Napier reports preliminary AUM $20.7B as of August 31 - Compared with $21B at July 31, and $21.3B at June 30.

16:04 EDT Gossamer Bio granted orphan status for pancreatic cancer treatment - The FDA granted GB006, a wholly owned subsidiary of Gossamer Bio, orphan status for its treatment of pancreatic cancer. Reference Link

16:02 EDT Alaska Air reports combined August traffic up 4.6% - On a combined basis for all operations, Air Group reported a 4.6% increase in traffic on a 4.2% increase in capacity compared to August 2018. Load factor increased 0.3 points to 86.0%.

15:42 EDT Ardelyx up 13.5% to $6.58 after resuming trade following FDA approval of Ibsrela

15:27 EDT Ardelyx says Ibsrela prescribing information includes Box Warning - Ardelyx announced that the FDA has approved Ibsrela, a 50 mg, twice daily oral pill for the treatment of irritable bowel syndrome with constipation, or IBS-C, in adults. Ibsrela is contraindicated in patients less than 6 years of age; in young juvenile rats, tenapanor caused death presumed to be due to dehydration. The FDA said to avoid use of Ibsrela in patients 6 years to less than 12 years of age. The safety and effectiveness of Ibsrela have not been established in pediatric patients less than 18 years of age. The full Prescribing Information includes a Box Warning about the risk of serious dehydration in pediatric patients. Reference Link

15:20 EDT Ra Medical committed to provide life improving products, President says - Ra Medical (RMED) develops and commercializes excimer lasers as tools for the treatment of vascular and dermatological diseases. In an exclusive interview with The Fly, the company's President Jeffrey Kraws discussed Ra Medical and its goals: "I would like to emphasize that the employees at Ra Medical are committed to doing everything possible to provide doctors and patients with products that improve their lives. Our dermatological products are treating various diseases, helping patients in many ways. And on the vascular side, our Dabra is saving limbs and lives. Overall, our goal is to make a positive difference in patients' lives." "Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company.

15:14 EDT Ardelyx receives FDA approval for Ibsrela - Ardelyx announced that the U.S. Food and Drug Administration has approved IBSRELA, a 50 mg, twice daily oral pill for the treatment of irritable bowel syndrome with constipation in adults. IBSRELA is a minimally-absorbed small molecule that acts locally in the gastrointestinal tract to inhibit the sodium-hydrogen exchanger NHE3, resulting in an increase in bowel movements and a decrease in abdominal pain for IBS-C patients. "IBSRELA has the potential to provide IBS-C patients and their doctors with a novel mechanism and an innovative approach to managing IBS-C, a highly burdensome and difficult-to-treat condition affecting more than 11 million people in the United States," commented Mike Raab, president and chief executive officer of Ardelyx. "This approval is an extremely important and rewarding milestone for Ardelyx, and represents the culmination of years of dedication to advancing our discoveries and medicines in an effective and rigorous manner. We look forward to establishing a commercial collaboration with a partner that has the capabilities to drive the successful launch and marketing of IBSRELA in this large and underserved IBS-C patient population."

14:45 EDT GlaxoSmithKline says FDA approves Nucala for use in children - GlaxoSmithKline announced that the FDA has approved Nucala for use in children as young as six years old who are living with severe eosinophilic asthma. Nucala is the only targeted biologic to be approved for the condition in the six to 11-year age group in the U.S. Nucala was first approved in 2015 as an add-on maintenance treatment for patients with severe eosinophilic asthma aged 12 years and older. This approval extends the current indication in the U.S. for Nucala to patients aged six to 11 years. Nucala has been approved for use as an add-on treatment for severe eosinophilic asthma in patients aged six years and older in the EU since August 2018.

14:39 EDT Ardelyx trading halted, news pending

14:36 EDT Ra Medical's RESULTS study to gather data over two years, Kraws says - Ra Medical (RMED) develops and commercializes excimer lasers as tools for the treatment of vascular and dermatological diseases. In an exclusive interview with The Fly, the company's President Jeffrey Kraws talked about Ra Medical's RESULTS study: "The study is named RESULTS, and that stands for revascularization rates clinical outcomes with Dabra laser long-term study. With regard to the study, we are conducting it to demonstrate that our Dabra Excimer Laser System delivers effective long-lasting results and a low re intervention rate for patients that suffer from Peripheral arterial disease. There are approximately 17.6M people we estimate in the United States that are afflicted by Peripheral arterial disease and less than 30% of them being treated today. Our study will gather data over two years post-treatment and up to 2,500 patients. Our Dabra laser system is a novel minimally invasive excimer laser photo ablation system that non thermally photochemically ablates channels and vascular blockages. Unlike many of the mechanical acoustic or thermal treatments for Peripheral arterial disease - there are competitors that may damage their arterial walls - our Dabra system treats blockages with minimal vascular trauma, and we hope to obtain results from this two years post-treatment." "Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company. The remainder of this interview to follow.

14:31 EDT Ardelyx trading halted, volatility trading pause

14:05 EDT Ra Medical President expects to file 10-Q 'as soon as possible' - Ra Medical (RMED) develops and commercializes excimer lasers as tools for the treatment of vascular and dermatological diseases. In an exclusive interview with The Fly, the company's President Jeffrey Kraws discussed the filing of Ra Medical's 10-Q: "We don't have an update on the filing of our 10-Q other than to say once the investigation concludes, we will file our Q as soon as possible." "Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company. The remainder of this interview to follow.

13:46 EDT Mylan dolutegavir combination application granted tentative approval by FDA - According to a post to the FDA website, Mylan's combination product containing dolutegavir, lamivudine, and tenofovir alafenamide fumarate was granted tentative approval by the FDA on September 11. Reference Link

13:34 EDT Ra Medical President says to provide update once investigation concludes - Ra Medical (RMED) develops and commercializes excimer lasers as tools for the treatment of vascular and dermatological diseases. In an exclusive interview with The Fly, the company's President Jeffrey Kraws talked about the ongoing CEO search and audit committee investigation: "We are going through the required processes to complete the investigation and we will provide an update once it's concluded. The CEO search is continuing to progress. As a company, we are very responsive to questions asked by investors and analysts. For the most part, once all questions are addressed and we go through our plan, people understand what we're doing - the potential as well as the risk-reward scenario that presents us today." "Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company. The remainder of this interview to follow.

13:00 EDT Pharos receiving 'very positive response,' Ra Medical's Kraws says

13:00 EDT Ra Medical to file 10-Q once investigation concludes, President Kraws says

13:00 EDT Ra Medical President confirms CEO search still underway

12:45 EDT United Technologies doesn't see any 'systemic' new issues for GTF engines

12:45 EDT United Tech CEO says has asked CFO Johri to stay on post-Raytheon merger - Confirms Toby O'Brien will be post-merger CFO.

12:37 EDT United Tech CEO sees aviation portfolio withstanding economic downturn

12:26 EDT United Tech CEO says working through senior executive team for Raytheon deal

12:25 EDT United Technologies CEO says Raytheon deal 'on track'

12:16 EDT BRT Apartments raises quarterly dividend 10% to 22c per share - BRT Apartments announced that its board of directors declared a quarterly dividend on the company's common stock of 22c, representing an increase of 2c per share, or 10% over the prior dividend payment. The dividend is payable October 10 to stockholders of record on September 25.

12:11 EDT B. Riley Financial appoints Dan Shribman as Chief Investment Officer - B. Riley Financil announced the appointment of Dan Shribman as Chief Investment Officer. He is based in New York. "I am pleased to announce Dan's promotion as our Chief Investment Officer," said Bryant Riley, Chairman and Co-CEO, B. Riley Financial. "Our continued growth provides us with a wider view of compelling ideas that benefit not only our clients, but also B. Riley. As the dynamic between active and passive continues to shift towards passive investing, our diversified platform provides us with unique insight and an ability to invest in and alongside our clients and partners, which in turn creates opportunities for us. Dan's significant experience and track record, along with flexibility in our balance sheet, has allowed us to further capitalize on the proprietary opportunities our growing platform offers."

12:06 EDT 3D Systems gets additional clearance for its D2, entry into POC market - 3D Systems announced it received additional clearance for its D2, DICOM-to-PRINT, software allowing clinicians to 3D print diagnostic patient-specific anatomic models. 3D Systems is the only company to offer a solution that combines its own software and printers to create 3D printed patient-specific anatomic models for diagnostic purposes in an unmatched breadth of medical specialties including: cardiovascular, craniofacial, gastrointestinal, genitourinary, neurological, and musculoskeletal applications. D2P relies on unique automatic segmentation tools driven by deep learning that allow medical practitioners to quickly create accurate, digital 3D anatomic models from medical imaging data. With the additional FDA clearance, D2P addresses the growing demand by point of care, POC, institutions for in-house manufacturing using an accurate and reliable 3D segmentation solution that can produce 3D printed models.

12:00 EDT American Renal Associates falls -16.4% - American Renal Associates is down -16.4%, or -$2.21 to $11.28.

12:00 EDT Tailored Brands falls -24.8% - Tailored Brands is down -24.8%, or -$1.78 to $5.39.

12:00 EDT Vapotherm rises 10.7% - Vapotherm is up 10.7%, or 93c to $9.63.

11:56 EDT General Electric CEO says feels 'pretty good' on operations

11:53 EDT General Electric CEO says improving operations 'is what takes longer'

11:50 EDT General Electric sets tender offers for up to $5B of existing debt - GE announced earlier its offers to purchase for cash: up to $2.5M aggregate purchase price of its U.S. Dollar-Denominated Debt Securities; and up to $2.5M aggregate purchase price of its Euro-Denominated Debt Securities. GE said the offers represents the next step in GE's stated strategy to strengthen the balance sheet and achieve GE Industrial leverage target of less than2.5X Net Debt / EBITDA. GE said it continues to evaluate potential deleveraging actions including but not limited to pension funding and intercompany loan repayment from GE to GE Capital and its related third-party debt.

11:24 EDT Enphase, SolarEdge slide after Citron recommends shorting on Generac challenge - Shares of Enphase Energy (ENPH) and Solaredge Technologies (SEDG) are both moving lower after Citron Research targeted the solar inverter manufacturers in a new short report. Andrew Left's Citron said he believes both stocks trade at "significantly inflated multiples on peak earnings even as a very credible competitive threat is about to enter the solar inverter market," namely Generac (GNRC). The latter company, which Citron says has taken number one market share in every market it enters, "has the resources and track record to make a huge dent in both SEDG and ENPH's market shares," the short-focused firm stated in its report. In morning trading, SolarEdge shares are down $1.50, or 2%, to $77.93 while Enphase shares have fallen $1.68, or nearly 7%, to $23.04. Reference Link

11:15 EDT Restoration Hardware trading resumes

10:57 EDT Honeywell CFO: 'If we see a great M&A opportunity, we'll take advantage of it' - Sees bolt-ons, smaller deals on the software side.

10:41 EDT Honeywell CFO says Aerospace continues to be 'very robust overall'

10:39 EDT Restoration Hardware trading halted, news pending

10:34 EDT FTE Networks exploring strategic alternatives to improve financial health - FTE Networks issued a letter to FTE shareholders regarding the Company's efforts and progress since the completion of its debt restructuring in July 2019. The letter from President and Interim CEO Fred Sacramone read, in part, "The Company has been expending significant efforts on many fronts to bring the Company current in its filings under the Securities Exchange Act of 1934, as amended. Management has been assisting outside counsel and consultants with the internal investigation of certain actions that was requisitioned by our Board of Directors and announced in a Form 8-K on March 22, 2019, preparing the restated financial statements for our 2016 and 2017 fiscal years and the financial statements for our 2018 fiscal year, and working with our outside auditors in their audit of such financial statements. Most importantly, we have been preparing the amended and most recent annual reports on Form 10-K and quarterly reports on Form 10-Q that will be filed with the Securities and Exchange Commission to make those financial statements available to the public and to include other disclosures that are required by the applicable federal securities laws. This has been a major effort on the part of management and we currently expect to make those filings with the SEC in the fourth quarter of this year. Additionally, the Company is currently exploring various strategic alternatives that would improve the Company's long-term financial health and operational effectiveness and address important legal issues resulting from certain actions taken by prior management, including but not limited to, additional financial and operational restructurings, sale or disposition of assets, and reviewing our legal remedies to recover funds and assets."

10:33 EDT Kroger says not reconfirming 3-year $400M incremental operating profit forecast - Comments taken from the Q2 earnings conference call.

10:17 EDT Google pays 500M euros to settle French probe into Irish taxes - Alphabet's Google has reached a settlement with France's Parquet National Financier to pay 500M euros regarding taxes at its Irish unit. Google's Irish unit failed to properly remunerate the subsidiary in France, thereby lowering the amount of taxes paid, French prosecutors alleged. Reference Link

10:00 EDT Innovative Industrial Properties acquires California portfolio for $17.3M - Innovative Industrial Properties announced that it closed on the final parcel of a four-property portfolio in southern California, which comprises approximately 79,000 square feet of industrial space in total. The purchase price for the southern California portfolio was approximately $17.3M in the aggregate. Concurrent with the closing of the purchase, IIP entered into a long-term, triple-net lease at each property with a subsidiary of Medical Investor Holdings for continued operation as licensed cannabis cultivation, extraction, manufacturing and distribution facilities in accordance with California regulations. Vertical is a multi-state operator licensed for cannabis cultivation, extraction, manufacturing and distribution in California and cultivation operations in Arizona and Ohio, with an extensive portfolio of branded cannabis products.

10:00 EDT DXC Technology falls -13.5% - DXC Technology is down -13.5%, or -$4.93 to $31.56.

10:00 EDT DRDGold rises 8.6% - DRDGold is up 8.6%, or 32c to $4.02.

10:00 EDT Britannia Bulk rises 9.3% - Britannia Bulk is up 9.3%, or 57c to $6.68.

09:47 EDT FTS International falls -12.6% - FTS International is down -12.6%, or -44c to $3.05.

09:47 EDT Tailored Brands falls -27.9% - Tailored Brands is down -27.9%, or -$2.00 to $5.17.

09:47 EDT Direxion Daily Jr Gld Mnrs Bull 3X Shrs rises 9.4% - Direxion Daily Jr Gld Mnrs Bull 3X Shrs is up 9.4%, or $6.40 to $74.20.

09:44 EDT RingCentral jumps 4% to $129.19 after Bloomberg report of Avaya JV talks

09:22 EDT Kodak adopts tax asset protection plan - Eastman Kodak announced that it has adopted a Tax Asset Protection Plan and filed an amendment to its certificate of incorporation in order to protect Kodak's substantial tax assets. The Plan and the amendment have been approved by the written consent of a majority of Kodak's common and preferred shareholders, and were described in an information statement mailed to Kodak shareholders on or about August 23. The Plan is designed to reduce the likelihood that Kodak will experience an ownership change that could adversely affect Kodak's tax assets by discouraging any person from becoming a holder of 10% of Kodak's common stock and by discouraging existing 10% shareholders from acquiring more than 1M additional shares. The amendment to the certificate of incorporation will generally restrict the transfer of Kodak common stock if the effect would be to increase the beneficial ownership of any person to 10% or more of the outstanding Kodak common stock or cause the beneficial ownership of an existing 10% shareholder to increase by more than 1M shares. Because of the treatment of outstanding convertible securities of the company, the Plan and amendment contain ownership thresholds of 10% or more of the company's common stock, rather than the 5% usually contained in such arrangements. There is no guarantee that the Plan or amendment will prevent Kodak from experiencing an ownership change. The Plan and amendment will expire on November 15.

09:19 EDT Corsair to fully exit position in CapStar Financial - CapStar Financial Holdings announced that it has been advised by the funds managed by Corsair Investments that Corsair entered into arrangements to fully exit its position in the Company through the sale of all of its remaining shares of Company common stock. In its last public filing of a Schedule 13G/A on February 13, 2019, Corsair stated that it held at that time 1,543,361 shares or 8.3% of the total number of fully diluted shares of common stock of the Company outstanding on such date.

09:16 EDT LKQ Corp. jumps after ValueAct reports activist stake - Shares of LKQ Corp., which provides parts to repair and accessorize automobiles, are moving higher after Jeffrey Ubben's ValueAct Capital disclosed a new activist stake in the company. In a filing with the SEC this morning, ValueAct reported a 5.2% stake in LKQ, which represents over 16M shares. ValueAct said it had, and will continue to have, discussions with officers and directors of LKQ about management, board composition, capital allocation, and its mergers and acquisitions strategy, among other topics. Shares of LKQ Corp. are up 5%, or $1.42, to $30.50 in premarket trading.

09:08 EDT T. Rowe Price reports preliminary AUM $1.12T at August 31 - Client transfers from mutual funds to other portfolios, including trusts and separate accounts, were $2.2B for the month and quarter-to-date period ended August 31. This brings total client transfers for the year-to-date period ended August 31 to $14.2B.

09:07 EDT Angi Homeservices appoints Michael Wanderer as chief people officer - ANGI Homeservices announced the promotion of Michael Wanderer to chief people officer, effective immediately. Previously SVP of People at Handy Technologies, which was acquired by ANGI Homeservices in October of 2018, Wanderer will now oversee global human resources, talent strategy and recruitment, retention and development at ANGI Homeservices, which includes leading brands HomeAdvisor and Angie's List in addition to Handy. MWanderer will report to ANGI Homeservices CEO Brandon Ridenour.

09:02 EDT SS&C to acquire Investrack Business - SS&C has entered into a definitive agreement wherein SS&C will acquire the Investrack business from UAE-based Globacom Technologies. The transaction is subject to customary closing conditions and is expected to close in September. Investrack will operate as a business unit under SS&C Advent adding 29 employees based in Dubai and Pune, India as well as 30 clients in 14 countries. The leadership team, including CEO Vijay Kartha will report to Mats Berggren, head of International business development of SS&C Advent. Through SS&C's long-term partnership with Globacom, Investrack's tools and services are already integrated with SS&C's solutions.

09:01 EDT Meredith reaches multi-year distribution agreement with DISH Network - Meredith (MDP) and DISH Network (DISH) agreed to a new multi-year retransmission consent agreement that has returned Meredith's local television stations to DISH customers in 12 U.S. markets, including Atlanta, Phoenix, St. Louis and Nashville.

08:52 EDT One Stop Systems wins design-in, purchase orders for flash array systems - One Stop Systems has won a major design-in and received initial purchase orders for its Ion Accelerator Flash Array systems. The initial purchase orders in support of this multi-year design win total $839,000. The Flash Array systems provide high-speed data storage for Oracle ERP systems used by a Fortune 500 electronics distribution company. The products ordered in the initial purchase orders are expected to ship in the third quarter of 2019.

08:49 EDT Omnitek Engineering announces strategic investment - Omnitek Engineering announced it has entered into a Securities Purchase Agreement with G.ON Global Investments SRL, with an investment of $640,000 at a price of $0.179 per share and an option to invest an additional $640,000 under the same terms. G.ON Global Investments SRL, a limited liability company organized under the laws of Romania, was established by one of the original founders of G.ON SRL, an Omnitek Engineering customer who engaged Omnitek in 2018 to develop a more than 400 hp 13-liter heavy-duty natural gas engine for Class 8 truck and bus applications. G.ON SRL will assemble the natural gas trucks utilizing the 13-liter engine. Omnitek Engineering will be the exclusive OE supplier of key natural gas engine management system components required for the engine to meet the EURO 6 emissions standard. Omnitek Engineering will have the distribution rights for Euro 6 Class 8 natural gas trucks in select countries, including: The United States of America, Mexico, South America, Israel, The United Arab Emirates and Nigeria.

08:44 EDT Greenlane enters into agreement with Jamestown for Higher Standards expansion - Greenlane Holdings announced a tenant representation agreement with Jamestown for the strategic North American expansion of its Higher Standards stores. Higher Standards opened its first flagship store at New York City's famed Chelsea Market in December 2017, followed by a second flagship store at Jamestown's Ponce City Market in Atlanta in March 2019. This partnership will drive further strategic expansion of the Higher Standards retail concept in key North American markets. Greenlane expects to have four Higher Standards stores operational in North America by year-end, with plans for continued domestic and international expansion.

08:43 EDT Kroger says net total debt to adjusted EBITDA ratio target range is 2.30-2.50 - Kroger reduced net total debt by $1.3B over the last four quarters. Kroger's net total debt to adjusted EBITDA ratio is 2.46, compared to 2.59 a year ago. The company's net total debt to adjusted EBITDA ratio target range is 2.30-2.50.

08:39 EDT General Electric announces FDA 510 clearance of Critical Care Suite - General Electric announced the FDA 510 clearance of Critical Care Suite, a collection of artificial intelligence, or AI, algorithms embedded on a mobile X-ray device. Built in collaboration with UC San Francisco, or UCSF, using GE Healthcare's Edison platform, the AI algorithms help to reduce the turn-around time it can take for radiologists to review a suspected pneumothorax, a type of collapsed lung. A prioritized X-ray can sit waiting for up to eight hours for a radiologist's review. However, when a patient is scanned on a device with Critical Care Suite, the system automatically analyzes the images by simultaneously searching for a pneumothorax. If a pneumothorax is suspected, an alert is sent directly to the radiologist for review via picture archiving and communication systems. The technologist also receives a subsequent on-device notification to give awareness of the prioritized cases.

08:35 EDT Kroger reports Q2 gross margin 21.9% of sales - Gross margin was 21.9% of sales for the second quarter. The FIFO gross margin rate, excluding fuel, decrease of 29 basis points was primarily driven by industry-wide lower gross margin rates in pharmacy and continued growth in the specialty pharmacy business. Gross profit excluding fuel and retail pharmacy saw 12 basis points of gross margin investment.

08:33 EDT Kroger reports Q2 identical sales, without fuel, up 2.2% - Reports Q2 digital sales up 31%.

08:30 EDT Proofpoint appoints Peter Leav, Leyla Seka to board of directors - Proofpoint (PFPT) announced its board of directors has appointed Peter Leav and Leyla Seka as new independent directors, effective July 24, 2019. Leav was most recently the president, chief executive officer, and director of BMC Software. Leyla Seka spent 11 years at Salesforce (CRM) where she most recently served as the executive vice president of the Salesforce Mobile platform experience.

08:27 EDT Amag urges shareholders to take no action on Caligan solicitation - AMAG Pharmaceuticals issued the following letter, which will be mailed to its shareholders. The letter said, in part, "You may soon receive consent solicitation materials from Caligan Partners LP, a hedge fund that accumulated its entire stake in AMAG Pharmaceuticals, Inc. within the past three months. Caligan has indicated that it intends to seek your written consent to remove and replace four members of your AMAG Board of Directors. Additionally, the Company is carefully reviewing the proposed ideas from Caligan, as it is concerned that certain actions pushed by Caligan may be destructive to the long-term value of the Company. The Board is committed to acting in the best interest of shareholders and maximizing long-term value creation, and remains steadfast in its belief that any corporate action taken must be for the benefit of all AMAG shareholders. Since 2017, the Company has made significant progress executing on its ambitious five-year strategic plan to develop and commercialize innovative products. In this timeframe, AMAG has successfully transformed from a specialty pharmaceuticals company with only two assets into a pharmaceutical company with four commercial therapies and two development-stage programs all while strengthening the financial profile of the Company. AMAG has streamlined and diversified its product portfolio and development pipeline through the divestiture of the CBR business and the acquisitions of AMAG-423 and ciraparantag and significantly strengthened its balance sheet through debt reduction and salesforce consolidation. Your Board believes that the removal of four highly-qualified and experienced members of the Board would be detrimental to the Company and our shareholders...It is imperative that shareholders take the necessary time to review relevant information, including the recommendation of AMAG's Board, before taking any action with respect to Caligan's consent solicitation. The Company intends to mail to you a consent revocation statement and accompanying GREEN consent revocation card, which will explain in more detail the Board's reasons for opposing Caligan's consent solicitation... We urge all shareholders to refrain from taking any action at this time and to WAIT for AMAG's consent revocation statement and GREEN consent revocation card. In the meantime, we urge all shareholders to disregard Caligan's consent efforts and discard any materials that may have been sent to you by Caligan."

08:19 EDT Hertz rises after Icahn boosts stake to 30.1% - In a regulatory filing earlier, Carl Icahn disclosed that he may be deemed to be the beneficial owner of, in the aggregate, 42,765,954 Hertz shares, including shares underlying forwards, representing approximately 30.1% of the company's outstanding shares. In pre-market trading, Hertz shares are up 31c, or 2% to $14.70.

08:13 EDT Aytu to issue stock, CVRs for up to $24M for Innovus deal - Under the terms of the merger agreement, Aytu (AYTU) will issue to Innovus shareholders a combination of stock and contingent value rights, subject to the achievement of certain milestones, for up to $24M. The number of shares to be issued will be determined based on a formula that adjusts the initial $8M purchase price for various deductions, such as amounts owed from Innovus (INNV) to Aytu under a promissory note, payments to be made to warrant holders, changes in Innovus liabilities and working capital, and other adjustments. The CVRs provide additional value of up to $16M if revenue and profitability milestones over the next five years are met.

08:11 EDT Aytu BioScience announces agremeent to acquire Innovus Pharmaceuticals - Aytu BioScience (AYTU) and Innovus Pharmaceuticals (INNV) announced that the companies have signed a definitive merger agreement whereby Aytu will retire all outstanding common stock of Innovus for an aggregate of up to $8M in shares of Aytu common stock, less certain deductions, at the time of closing. This initial consideration to Innovus common shareholders is estimated to consist of approximately 4.2 million shares of Aytu stock. Additional consideration for up to $16M in milestone payments in the form of contingent value rights may be paid to Innovus shareholders in cash or stock over the next five years if certain revenue and profitability milestones are achieved. Innovus generated more than $24M in revenue in the four quarters ending June 30, 2019. Initially, the company expects to operate the commercial aspects of the Innovus consumer business separately from Aytu's prescription business, while rationalizing general and administrative expenses through the removal of Innovus' public company costs and redundant administrative and operational processes, along with the reduction in overhead, administrative and facilities costs. The board of directors of both companies have approved the terms of the merger transaction which is subject to the approval of both companies' shareholders. At the time of signing, Aytu had collected voting agreements supporting the merger transaction that represent approximately 35% of current shares outstanding. Innovus has thus far collected voting agreements supporting the transaction that represent approximately 17% of shares outstanding. The transaction, which is expected to close as early as Aytu's second fiscal quarter of 2020 and is subject to customary closing conditions and regulatory approvals.

08:10 EDT Sky Italia to deliver new video streaming service with Harmonic - Harmonic announced that Sky Italia will launch a new video streaming service using Harmonic's cloud-native media processing software and content-aware encoding technology. The Harmonic solution is integrated into the Sky Italia hybrid cloud software-defined streaming platform. Leveraging the latest advancements in pure software architecture, the Harmonic solution provides Sky Italia with the agility, flexibility and scalability to speed up the launch of new premium services and enable delivery of superior video quality at low bitrates.

08:07 EDT CACI awarded position on $17.1B DIA contract - CACI announced it has been awarded a position on a multiple-award, indefinite delivery/indefinite quantity contract with the Defense Intelligence Agency, or DIA, with a ceiling value of $17.1B, to support military intelligence operations for defense planners, warfighters and policy makers. Work performed under the Solutions for Intelligence Analysis 3, or SIA 3, contract vehicle will focus on delivering intelligence analysis and analytic enabling support to the DIA and its Defense Intelligence Enterprise mission partners through military intelligence spanning mission task areas including counter intelligence, human intelligence and engineering. The 10-year award continues CACI's participation in the SIA programs.

08:05 EDT Ovid Therapeutics announces first patient randomized in Phase 3 NEPTUNE trial - Ovid Therapeutics announced that the first patient has been randomized in the company's single, pivotal Phase 3 NEPTUNE clinical trial evaluating OV101, a novel delta-selective GABAA receptor agonist, in Angelman syndrome. The company anticipates topline data from the trial to be available in mid-2020. NEPTUNE is a randomized, double-blind, placebo-controlled, Phase 3 clinical trial designed to assess the effects of treatment with OV101 versus placebo over 12 weeks. The trial will include approximately 60 pediatric patients ages 4 to 12 years diagnosed with Angelman syndrome. The sole primary endpoint will be change in overall score on the Clinical Global Impression-Improvement-Angelman syndrome scale. Secondary endpoints include sleep, communication, motor function, socialization, daily living skills and behavior domains. A limited number of children, ages 2 to 3 years, will also be enrolled in the study to evaluate OV101's pharmacokinetics along with safety and tolerability in this younger age group. Participants who complete the NEPTUNE trial will be eligible to roll over into the ongoing open-label extension trial should they choose to do so.

08:03 EDT Curis names Bill Steinkrauss as CFO - Curis announced the promotion of Bill Steinkrauss to CFO. Steinkrauss joined Curis in August 2016 and most recently served as Treasurer and Vice President of Finance. Prior to joining Curis, he served as Director of Technical Accounting and Reporting at Ovascience and Senior Manager of Technical Accounting at Cubist Pharmaceuticals.

08:01 EDT Legg Mason reports AUM of $776.8B at August 31 - Legg Mason reported preliminary assets under management, or AUM, of $776.8B as of Aug. 31. This month's AUM included long-term net inflows of $0.8B, driven by positive inflows in all three asset classes, including $0.4B in fixed income, $0.3B in alternatives, and $0.1B in equities. AUM also included net liquidity outflows of $4.4B and negative foreign exchange impact of $1.4B.

07:53 EDT BioSig Technologies signs licensing agreement with Mayo Clinic - BioSig Technologies announced that it signed a new licensing agreement with Mayo Clinic. The new agreement aims to develop a new product pipeline to support some of the more advanced features of BioSig's first product, PURE EP System. The development program will be run under the leadership of Samuel J. Asirvatham, M.D., Mayo Clinic's Vice-Chair of Innovation and Medical Director, Electrophysiology Laboratory.

07:41 EDT Ero Copper intersects 31.8 meters grading 2.22% copper at Siriema discovery - Ero Copper provided a quarterly update on the ongoing exploration drill programs on its 99.6% owned Vale do Curaca Property located in Bahia State, Brazil, and on its 97.6% owned NX Gold Mine located in Mato Grosso State, Brazil. This update encompasses drill results received from the end of May through to the end of August 2019. Exploration drilling during the period was focused primarily on expanding recently announced discoveries as well as infill drilling ahead of the Company's updated National Instrument 43-101, Standards of Disclosure for Mineral Projects compliant technical report and mine plan for the Vale do Curaca Property, expected to be completed early in the fourth quarter of 2019. High-grade massive sulphide mineralization continues to be encountered at the recently announced Siriema discovery, highlighted by hole FSI-42 that intersected 31.8 meters grading 2.22% copper including 5.0 meters grading 5.56% copper; Near-surface drilling adjacent to the Vermelhos Mine in the Vermelhos East Zone intersected 22.5 meters grading 4.60% copper including 8.0 meters grading 7.76% copper from 7.7 meters down-hole in hole FVS-418, one of the highest-grade intercepts drilled into the East Zone to date. A grouping of holes in the Deepening Extension of the Pilar Mine intercepted high-grade mineralization, including the deepest known mineralized intercept drilled to date in hole FC47139 that intersected 7.1 meters grading 6.50% copper including 4.1 meters grading 9.01% copper, approximately 80 meters below the previous known depth of mineralization at the Pilar Mine. Underground drilling to further evaluate the southern extent of the Pilar Mine orebody within the South Extension zone continues to intercept thick and high-grade mineralization, highlighted by hole FC34100 that intersected 25.5 meters grading 1.47% copper including 2.0 meters grading 5.85% copper. Twenty-seven drill rigs are now operating throughout the Curaca Valley, including fifteen within the Pilar District and twelve within the Vermelhos District. This includes two rigs operating at the recently announced Siriema discovery and four rigs operating on regional targets within the Pilar and Vermelhos Districts. There are currently three additional drill rigs operating at the NX Gold Mine.

07:37 EDT TG Therapeutics presents ublituximab data at ECTRIMS Congress - TG Therapeutics presented the first look at the ULTIMATE I & II Phase 3 trial design and demographic data and updated Phase 2 extension trial data for ublituximab, the Company's novel, glycoengineered anti-CD20 monoclonal antibody, in relapsing forms of multiple sclerosis at the 35th Annual Congress of the European Committee for Treatment and Research in Multiple Sclerosis. The following summarizes the highlights from each presentation during the 35th ECTRIMS meeting: Title: Study Design and Patient Demographics of the ULTIMATE Phase III Trials Evaluating Ublituximab, a Novel Glycoengineered Anti-CD20 Monoclonal Antibody, in Patients with Relapsing Multiple Sclerosis. This presentation includes the study design and demographic data from ULTIMATE I & II, two identical, randomized, international, multi-center, double-blinded, double dummy, active controlled Phase 3 trials, evaluating a twice per year one-hour 450mg infusion of ublituximab in RMS. These trials are being conducted under Special Protocol Assessment agreement with the U.S. Food and Drug Administration and are being led by Lawrence Steinman, MD, of Stanford University. Presentation Highlights: Patient recruitment for ULTIMATE I & II was successfully completed in the second half of 2018. Baseline characteristics of patients enrolled in ULTIMATE I & II are consistent with a typical RMS population. The ULTIMATE I & II trials are expected to elucidate the therapeutic potential of a one hour, 450mg infusion of ublituximab in patients with RMS. Topline results are expected in the second half of 2020. Title: Long-term Follow-up Results from the Phase 2 Multicenter Study of Ublituximab, a Novel Glycoengineered Anti-CD20 Monoclonal Antibody, in Patients with Relapsing Multiple Sclerosis. This presentation includes long-term follow-up data for 45 patients from the Phase 2 trial that enrolled into the Open Label Extension trial and recaps the final efficacy data on patients enrolled in the Phase 2 study through 48 weeks of treatment. Presentation Highlights: Ublituximab continues to be well tolerated, with a median duration of follow-up of 124.7 weeks. No subjects discontinued due to an Adverse Event related to ublituximab on the Phase 2 or during the OLE. AEs deemed at least possibly related to ublituximab were infrequent during the OLE with all patients dosed at 450mg of ublituximab administered in a one-hour infusion. Infusion Related Reactions were rare during the OLE, occurring in only 5 patients, all Grade 1 or 2. An Annualized Relapse Rate of 0.07 was observed with 93% of subjects relapse free at Week 48.

07:35 EDT Elite Pharmaceuticals receives FDA approval for codeine, acetaminophen combo - Elite Pharmaceuticals announced that it received approval from the US Food and Drug Administration for an Abbreviated New Drug Application for a generic version of Tylenol with Codeine 300mg/15mg, 300mg/30mg, and 300mg/60mg tablets.

07:12 EDT Valeritas presents CBD h-Patch data from preclinical pharmacokinetic study - Valeritas Holdings announced positive data from a preclinical pharmacokinetic study of cannabidiol subcutaneous infusion was presented at the 2nd Annual International Cannabinoid-Derived Pharmaceuticals Summit in Boston, Massachusetts. Data presented at the Summit showed rapid and robust absorption and distribution of 40mg CBD delivered over 24 hours with the h-Patch technology. CBD was detected within one hour of the start of infusion, followed by prolonged elimination with near steady state levels still detectable 24 hours after completion of h-Patch infusion, or 48 hours in total. These data demonstrated that subcutaneous infusion of CBD of 40mg with the h-Patch provided peak plasma levels on par with published human dose-normalized plasma concentrations from a single oral administration of 300mg CBD. Valeritas' h-Patch is a drug delivery technology that can facilitate the simple and effective subcutaneous delivery of injectable medicines to patients across a broad range of therapeutic areas. The Company's V-Go is the an FDA-approved product that utilizes the h-Patch technology. To date, more than 20M V-Go insulin delivery devices have been sold in the United States.

07:07 EDT Alta Mesa Resources promotes Mark Castiglione to CEO - Alta Mesa Resources announced that its Board of Directors has approved several leadership changes, in addition to prior personnel decisions that the Companies have made. These changes, which are effective immediately, will help provide a more optimal management structure for the future and reduce general and administrative costs. Jim Hackett, who recently held the title of Interim CEO, has resumed his former role as Executive Chairman and will remain involved with the Board and management team in the restructuring process. Mark Castiglione, who was previously Interim EVP Strategy and Corporate Development, has been promoted to CEO. Randy Limbacher, formerly Interim President, has accepted the role of EVP of Strategy, and will provide strategic counsel to the management team and Board. John Campbell, formerly Interim COO, has become President and COO. Kim Warnica will continue as EVP, General Counsel, CCO and Secretary, while John Regan will remain EVP and CFO.

07:06 EDT Alta Mesa Resources, Alta Mesa Holdings file voluntary bankruptcy petition - Alta Mesa Resources, Alta Mesa Holdings, Alta Mesa Finance Services Corp., Alta Mesa Services and Oklahoma Energy Acquisitions announced that they have filed a voluntary petition under Chapter 11 of the United States Bankruptcy Code. The Companies' midstream platform, Kingfisher Midstream, LLC and its subsidiaries are not debtors and are not part of the Chapter 11 reorganization process. Jim Hackett, Executive Chairman of Alta Mesa Resources, commented "We believe that the Chapter 11 process provides the best pathway for Alta Mesa Resources and Alta Mesa Holdings to restructure their respective balance sheets and to regain the financial flexibility necessary to develop their large position in the STACK in a manner that will maximize value for all their stakeholders." Despite considerable progress in reducing costs and improving well results, the Companies continue to operate against a historically challenging commodity price environment and a capital market that is highly constrained for energy companies. Ultimately, these factors made bankruptcy protection the best option for the Companies as they continue production operations while negotiating with their lenders.

07:02 EDT Och-Ziff Capital changes name to Sculptor Capital Management - Och-Ziff Capital Management Group announced that it changed its name to Sculptor Capital Management, The Company's Class A common stock, which previously traded on the NYSE under the ticker symbol "OZM," began trading under the new ticker symbol NYSE: SCU. The company said, "The name change marks an important milestone for the Company. It recognizes the changes in leadership and governance the Company implemented earlier this year which transferred ownership and control to the Executive Managing Directors while establishing long term incentives that align the EMDs and the Company's fund investors."

06:56 EDT Waddell & Reed reports preliminary AUM $69.6B as of August 31 - Compared to $71.5B on July 31.

06:50 EDT Tapestry announces strategic alliance with Alibaba's Tmall - Tapestry (TPR) announces a strategic partnership with Alibaba's (BABA) Tmall, China's largest B2C ecommerce platform. This alliance marks a step forward in Tapestry's ChinaNext digital innovation agenda. Tapestry will be one of the first companies to collaborate with Tmall in adopting the recently unveiled Flagship Store 2.0, beginning later this month. The upgraded platform will provide Tapestry's brands with powerful tools to feature customized content, and offer elevated, rich shopping experiences for customers. In addition, this platform will allow Tapestry's industry leading and innovative Data Labs team to gain deep insights into the local market as the Company continues to focus on driving growth in the region with seamless experiences both offline and online. As part of this partnership, the Coach, Kate Spade and Stuart Weitzman brands will all have flagship stores on Tmall Luxury Pavilion, Alibaba Group's dedicated platform for luxury and premium brands. These flagships will not only feature products exclusive to Tmall, but also offer personalized content and services according to customers' preferences. Additionally, Tapestry and Alibaba will continue to strengthen their collaboration on intellectual property rights protection. Tapestry's Coach is a member of the Alibaba Anti-Counterfeiting Alliance, leveraging Alibaba's tools, technology and cooperation initiatives to protect its brand.

06:38 EDT U.S. Bancorp sees 'challenging' rate environment through 2020

06:36 EDT U.S. Bancorp revises long-term growth targets ahead of investor day

06:35 EDT Moderna reports 'positive' Phase 1 results from study of mRNA-1944 - Moderna announced positive data in the first analysis of safety and activity in its Phase 1 study evaluating escalating doses of mRNA-1944 administered via intravenous infusion in healthy adults. mRNA-1944 encodes for an antibody with activity against chikungunya virus. At all three dose levels, the administration of mRNA-1944 led to detectable levels of CHKV-24 antibody in all participants, ranging from 1 microg/mL to 14 microg/mL. These results mark the first systemic mRNA therapeutic to show production of a secreted protein in humans. mRNA-1944 is being developed with financial support from the Defense Advanced Research Projects Agency, an agency of the U.S. Department of Defense. mRNA-1944 is the first development candidate from the company's systemic therapeutics modality to start clinical testing and utilizes the same lipid nanoparticle formulation as the company's rare disease program for methylmalonic acidemia. A total of 22 healthy adults have been enrolled in the study to date. The initial analysis evaluated the safety and pharmacology of intravenous administration of mRNA-1944 at three dose levels of 0.1 mg/kg, 0.3 mg/kg, and 0.6 mg/kg; six participants received placebo. Administration of mRNA-1944 resulted in dose-related increases in CHKV-24 antibody levels, with average Cmax antibody levels of 2.0, 7.9 and 10.2 ug/mL at the low, middle and high doses, respectively. At all doses, all participants exceeded the levels of antibody expected to be protective against chikungunya infection following a single dose, with the middle and high doses projected to maintain antibody levels above protective levels for at least 16 weeks. All participants also showed circulating neutralizing antibody activity against chikungunya virus replication in an NT50 assay, demonstrating that mRNA-1944 resulted in the production of fully functional protein in vivo. All participants in the study received antihistamine premedication. No participants received corticosteroids either as premedication or treatment. None of the participants treated with mRNA-1944 at the low or middle doses experienced significant adverse events. Three of the four participants at the high dose had infusion-related AEs, with the highest grade by subject being Grade 1, Grade 2 and Grade 3. The Grade 3 AEs were tachycardia and an elevated white blood cell count. The same participant experienced Grade 2 AEs of nausea, emesis, fever and inverted T waves on a routine EKG (without associated cardiac symptoms and which later resolved). The fourth participant at the high dose had no related adverse events. There were no meaningful changes in liver or kidney laboratory results. There have been no serious AEs in the study. All AEs were transient and resolved spontaneously without treatment.

06:10 EDT British American Tobacco to cut around 2,300 roles globally - British American Tobacco announced a step in a program to simplify its business and create a more efficient, agile and focused BAT. This will ensure the company is better placed to meet ever-evolving consumer needs and deliver savings that can be reinvested in the growth of its portfolio of New Categories such as vapor, tobacco heating products and oral tobacco, the company said in a statement. To enable better focus on key growth areas; faster decision making; greater management accountability and the elimination of duplicative activities, the proposals will: reduce management layers; create fewer larger more accountable business units; better leverage its Global Business Services activities; and simplify all key business processes and "ways of working." The program, which is planned to be substantially complete by January 2020, envisages a reduction of around 2,300 roles globally. With the focus on simplification and removal of management layers, it is expected that over 20% of the senior roles in the organization will be affected. A consultation process is now underway with all staff who will be impacted. Jack Bowles, CEO, said: "Since taking on the role of Chief Executive five months ago, I have been clear that I wanted to make BAT a stronger, simpler and faster organization and ensure a future fit culture. My goal is to oversee a step change in New Category growth and significantly simplify our current ways of working and business processes, whilst delivering long-term sustainable returns for our shareholders. This is a vital first move to help achieve these goals... As a result, BAT will be better placed to deliver on our target of generating GBP 5 billion of revenues in New Categories by 2023/24." Reference Link

06:02 EDT Tocagen says Toca 5 Phase 3 clinical trial missed primary endpoint - Tocagen announced that the Toca 5 Phase 3, randomized, multi-center clinical trial evaluating Toca 511 & Toca FC in patients with recurrent high grade glioma, or HGG, undergoing resection missed the primary endpoint of overall survival compared to standard of care treatment. In addition, all secondary endpoints showed no meaningful difference between the arms of the trial. The safety, tolerability and adverse event profile of Toca 511 & Toca FC was as expected for this patient population. Further analysis of the Toca 5 trial data is currently underway and presentation of the results is planned at an upcoming medical conference.

06:02 EDT Wabco signs three-year agreement to be Anchor Partner with Plug and Play - Wabco has signed a three-year agreement to be an Anchor Partner with Plug and Play, a global innovation platform leader headquartered in Silicon Valley, U.S. Under the agreement, Wabco will gain access to Plug and Play's extensive global partnership network which includes many of the best startups, market disruptors and industry leaders, enabling the co-creation of advanced new solutions and joint innovation initiatives. The collaboration will also powerfully leverage Plug and Play's proven innovation capabilities to support the advancement of Wabco's Autonomous, Connected and Electric vehicle and transport ecosystem technologies.

05:33 EDT Vertex announces new access agreement with Scotland for Orkambi, Symkevi - Vertex Pharmaceuticals announced that eligible cystic fibrosis patients living in Scotland will now have access to Orkambi and Symkevi in combination with ivacaftor following the signing of an access agreement. As part of the 5-year agreement Vertex has also committed to collecting real world data on these medicines that will support any future submissions to the Scottish Medicines Consortium.

05:27 EDT Genentech says satralizumab 'significantly' reduced relapse risk in second study - Genentech, a member of the Roche Group, presented full pivotal Phase III study results for satralizumab as a monotherapy for neuromyelitis optica spectrum disorder, or NMOSD, a rare, debilitating central nervous system disease. Results from the SAkuraStar study, presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, or ECTRIMS, show that satralizumab monotherapy achieved a 55% reduction in the risk of relapses compared to placebo in the overall population, representative of NMOSD patients. In the large subgroup of patients seropositive for AQP4-IgG antibodies, the effect was higher with a 74% reduction in risk of relapses. People who are AQP4-IgG seropositive tend to experience a more severe disease course. "The positive Phase III results for satralizumab, first as an add-on therapy and now as a monotherapy, are exciting to see, and importantly, satralizumab achieved efficacy in a broad range of NMOSD patients, reflective of what we see in our everyday practice. Satralizumab targets the IL-6 receptor, potentially offering a novel treatment approach," said Professor Jeffrey Bennett, University of Colorado Neurology & Ophthalmology. "Approved treatment options demonstrating favorable safety and efficacy in controlled clinical trials are urgently needed. Even one relapse may lead to blindness and debilitating motor dysfunction for people with NMOSD."

05:11 EDT Walmart expands 'Delivery Unlimited' grocery delivery to 1,400 stores - Walmart has plans to expand the reach of Delivery Unlimited - a Grocery Delivery membership option for customers - to 1,400 stores later this fall. The program gives customers the option to pay a yearly $98 fee or a monthly $12.95 fee to receive unlimited Walmart Grocery Delivery orders. Customers will continue to have the option to pay a per-delivery fee, without a membership.