Stockwinners Market Radar for October 02, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:30 EDT Newmark acquries Workframe, terms not stated - Newmark Group announced that it has acquired the innovative workflow solutions provider Workframe, Inc. The Workframe software tool is a "workflow solution that was built to address the unique complexity of the CRE project lifecycle."

19:43 EDT Organovo acknowledges receipt of acquisition proposal from Viscient Biosciences - Organovo confirmed that it has received a proposal from Viscient Biosciences, an early-stage private company headquartered in San Diego, CA to acquire ownership control of Organovo. As disclosed in August 2019, Organovo's board determined that it would be in the best interests of Organovo's stockholders to evaluate Organovo's strategic alternatives. A Special Committee of the Board has retained Roth Capital Partners to act as its financial advisor. Organovo intends to evaluate Viscient's proposal in due course, and is not asking its stockholders to take any action at this time.

19:00 EDT Ecolab acquires Gallay Medical & Scientific, terms not disclosed - Ecolab has acquired Gallay Medical & Scientific, a distributor of endoscopy, central sterile department, dental and pharmaceutical solutions in Australia and New Zealand. Headquartered in Melbourne the company's sales for the fiscal year ending June 30, 2019, were approximately AU$42M. "Ecolab is committed to providing hospitals and healthcare facilities throughout the world with innovative infection prevention solutions for patients and healthcare providers," said Gergely Sved, senior vice president and general manager of Ecolab Healthcare. "Gallay Medical & Scientific, founded and operated by the Vat family, is a well-respected distributor of medical solutions that shares our focus on technical and service excellence, and will enable us to meet the needs of our growing customer base in Australia and New Zealand."

18:20 EDT GoPro down 17% after delaying shipments of HERO8 Black, cutting guidance - In after-hours trading, shares are down 17.4% to $4.24.

18:09 EDT GoPro: HERO8 Black shipments will shift from Q3 to Q4 due to production delay - On October 2, GoPro hosted an investor conference call to announce certain product and financial information and comment on updated financial guidance for the full year 2019. On the conference call, the company announced the following: The launch of two new cameras with significant performance improvements, the HERO8 Black and MAX, and three new accessory packages, the Media Mod, Display Mod, and Light Mod. HERO8 Black and MAX are available for preorder at GoPro.com with first shipments going out October 15 and global on-shelf availability beginning the week of October 20. Due to a late stage production delay, HERO8 Black shipments will shift from the third quarter to the fourth quarter of 2019, resulting in a significant revenue shift between the quarters. Comments taken from 8k filing.

17:42 EDT Lockheed Martin awarded $163.95M Air Force contract modification - Lockheed Martin has been awarded a $163.95M fixed-price, incentive-firm target modification to previously awarded contract for space based infrared system contractor logistics support. This action is a bilateral supplemental agreement executed in accordance with justification and approval 18-14. Work is expected to be completed by September 30, 2020. FY20 operations and maintenance funds are used and no funds are being obligated at the time of the award. The total cumulative face value of the modification is $163.95M. The Air Force Space and Missile Systems Center is the contracting activity.

17:25 EDT S&P announces changes to S&P MidCap 400, S&P SmallCap 600 indices - S&P Dow Jones Indices will make the following changes to the S&P MidCap 400 and S&P SmallCap 600: Mercury Systems (MRCY) will replace Versum Materials (VSM) in the S&P MidCap 400, and Cleveland-Cliffs (CLF) will replace Mercury Systems in the S&P SmallCap 600 effective prior to the open of trading on Tuesday, October 8. Merck KGaA (MKGAY) is acquiring Versum Materials in a deal expected to be completed on or about that date pending final conditions. Essential Properties Realty Trust (EPRT) will replace Navigant Consulting (NCI) in the S&P SmallCap 600 effective prior to the open of trading on Friday, October 11. Veritas Capital Fund Management is acquiring Navigant Consulting in a deal expected to be completed on or about that date pending final conditions.

17:23 EDT Bed Bath & Beyond says it now plans to close around 60 total stores in FY19 - Says completed a workforce reduction that effected 7% of corporate staff. Says leveraging fleet optimization program. Says outsourcing will lead to the cutting of 80 positions later in the year. Says plans to reduce up to $1B of inventory at retail over the next 18 months. Says over $350M of inventory at retail to be removed from stores before 2019 holiday season. Comments taken from Q2 earnings conference call.

17:20 EDT Mercury Systems to replace Versum Materials in S&P 400 at open on 10/8 - Merck KGaA (MKGAY) is acquiring Versum Materials (VSM) in a deal expected to be completed on or about that date pending final conditions.

17:01 EDT Tesla down 5.7% to $229.20 after reporting Q3 deliveries

16:40 EDT Bed Bath & Beyond says has made 'substantial progress' in CEO search - The company has made substantial progress toward identifying a permanent CEO. The company remains on track with its expectation that it will make an announcement soon.

16:35 EDT Tesla says produced 96,155 vehicles, delivered 97,000 vehicles in Q3 - In the third quarter, Tesla said it achieved record production of 96,155 vehicles and record deliveries of approximately 97,000 vehicles. For the Model S/X, the company produced 16,318 vehicles and delivered 17,400 vehicles. For the Model 3, the company produced 79,837 vehicles and delivered 79,600 vehicles. In addition, Tesla said it "achieved record net orders in Q3" and is entering Q4 with an increase in its order backlog. As was also the case in Q2, nearly all of its Model 3 orders were received from customers who did not previously hold a reservation, solidifying the transition to generating strong organic demand. Tesla said it is continuing to focus on increasing production to meet that demand. Tesla noted that its delivery count should be viewed as slightly conservative, as it only counts a car as delivered if it is transferred to the customer and all paperwork is correct. Final numbers could vary by up to 0.5% or more.

16:32 EDT GCP Applied Technologies CFO Dean Freeman to step down, backs FY19 guidance - GCP Applied Technologies announced that Dean Freeman, Vice President and CFO, is leaving the company to pursue another opportunity. Craig A. Merrill, Vice President, Finance, Analytics and Strategy, has been appointed Interim CFO, effective following Mr. Freeman's resignation on October 15, 2019, and will report directly to GCP's President and CEO, Randall S. Dearth, until a permanent replacement is named. GCP is conducting a comprehensive search process with the assistance of a leading executive search firm to identify a permanent CFO. GCP also reaffirmed its previously announced outlook for FY19.

16:29 EDT Circor wants to sell Distributed Valves unit in shift from upstream oil & gas - Circor announced its intent to sell its Distributed Valves business, consistent with its strategic shift away from upstream oil & gas. "This is an important step in Circor 's transformation as we continue to diversify away from upstream oil & gas and focus on more attractive end markets with enhanced growth and earnings potential," said Scott Buckhout, President and Chief Executive Officer of Circor . "In conjunction with this strategic shift, the Energy Group's overhead will be optimized by the end of the year, which is expected to generate annual run rate savings of approximately $4 million." "The management team is successfully executing the company's strategic plan and will continue to take the necessary actions that will best position Circor to deliver enhanced value for shareholders," concluded Buckhout. These actions, along with the divestiture of Engineered Values, are consistent with the 18-month plan communicated in June 2019. The company's segment operating loss attributable to the Distributed Valves and Engineered Valves businesses was approximately $8M for the six months ended June 30. Distributed Valves and Engineered Valves will be reported as discontinued operations.

16:25 EDT Stitch Fix discloses 'critical audit matter' related to inventory reserve - In a regulatory filing, Stitch Fix disclosed what it describes as a "critical audit matter", stating in part: "The company establishes an inventory reserve, which includes a reserve for excess and slow-moving inventory on hand that is expected to be written-off or otherwise disposed of at a future date. The company's estimate of the appropriate amount of the excess and slow-moving inventory reserve utilizes certain inputs and involves judgment. Such inputs include data associated with historic trends, historic inventory write-off activity, and the on-hand inventory aging distribution. The calculation and analysis of historic trend data, historic write-off activity, and the application of this analysis to on-hand inventory involves complex calculations. The excess and slow-moving inventory reserve at August 3, 2019 totaled $18M. Net inventory at August 3, 2019 totaled $118M. We identified the inventory reserve as a critical audit matter because of the significant estimates and assumptions management makes to estimate the excess and slow-moving inventory reserve, especially considering the introduction of newer product lines and changes in the inventory management process. This required a high degree of auditor judgment and an increased extent of effort when performing audit procedures to evaluate the methodology and the reasonableness of related assumptions, as well as the inputs and related calculations related to historic inventory trends, historic inventory write-off activity, and the on-hand inventory aging distribution."

16:20 EDT Bed Bath & Beyond interim CEO says 'making good progress' against priorities - Mary Winston, Interim CEO, stated, "We are making good progress against our four key near-term priorities, including: (1) stabilizing sales and driving top-line growth; (2) resetting the cost structure; (3) reviewing and optimizing the Company's asset base, including the portfolio of retail banners; and (4) refining our organization structure. Our second quarter financial results reflect the relentless effort of our teams and our progress in driving the Company's transformation efforts to delight our customers, enhance our competitive position, improve our financial performance, and drive shareholder value."

16:17 EDT Transocean deploys hybrid energy storage system aboard floating drilling unit - Transocean announced that it has successfully deployed the world's first hybrid energy storage system aboard a floating drilling unit. The system is now operational on the Transocean Spitsbergen, engaged in drilling operations at the Snorre field in Norway. Transocean's patented hybrid power technology, developed in partnership with Aspin Kemp and Associates, reduces fuel consumption and increases a dynamically positioned rig's station-keeping reliability by capturing energy generated during normal rig operations that would otherwise be wasted, and storing it in batteries. This energy is then used to power the rig's thrusters. This important operational and safety enhancement targets a 14% reduction in fuel use during normal operations, leading to a significant reduction in NOx and CO2 emissions.Transocean's investment is funded in part through fuel saving incentives in its contract with Equinor and by the Norwegian NOx Fund. "This first of its kind hybrid power upgrade will further enhance the reliability of our operations, while simultaneously reducing fuel consumption, operating costs and our environmental footprint," said Jeremy Thigpen, President and CEO. "We are pleased and proud to work alongside Equinor to jointly identify and implement more efficient and sustainable technology to deliver high-value wells to the industry."

16:16 EDT Puma Biotechnology gets FDA labeling supplement approval for Nerlynx - Puma Biotechnology announced that the FDA has approved a labeling supplement for NERLYNX, or neratinib, for the extended adjuvant treatment of HER2-positive early stage breast cancer. With the approval of the labeling supplement, the label now includes safety information based on interim results from Puma's Phase II CONTROL Trial, a study evaluating antidiarrheal prophylaxis or dose escalation in the reduction of neratinib-associated diarrhea that has a primary endpoint of the incidence of grade 3 or higher diarrhea. Interim data from the trial showed that the addition of prophylactic treatment with loperamide plus budesonide reduced the discontinuation rate due to neratinib-associated diarrhea to 11% versus a discontinuation rate of 18% with loperamide alone.

16:16 EDT Bed Bath & Beyond reports Q2 SSS down approximately 6.7%

16:09 EDT CSX appoints Kevin Boone as CFO, Jamie Boychuk as EVP of operations - CSX announced the appointments of Kevin Boone as executive vice president and CFO and Jamie Boychuk as executive vice president of Operations. Ed Harris, who previously led the Operations function, will continue as executive vice president with a combination of operating and general executive responsibilities. "Both Kevin and Jamie have played a significant role in the company's recent transformation and are great additions to our executive team," said CSX President and Chief Executive Officer James M. Foote. "Kevin's strong and diverse finance background will be invaluable as we strive to operate efficiently and create shareholder value."

16:06 EDT E-Trade announces zero base rate commissions on stock, ETF, options trades - E*TRADE announced it will eliminate retail commissions for online US listed stock, ETF, and options trades. It will also reduce the options contract charge to $0.65 per contract for all traders while maintaining its active trader pricing at $0.50 per contract. These changes will take effect on October 7, 2019. The company estimates that the revenue impact of the commission changes on Q2 2019 operating results would have been approximately $75M.

16:00 EDT Trecora Resources trading resumes

15:27 EDT Trecora Resources trading halted, news pending

14:44 EDT U.S. Steel falls after S&P revises outlook to negative on Big River acquisition - Shares of United States Steel (X), which produces and sells flat-rolled and tubular steel products primarily in North America and Europe, are falling along with major market indices after rating agency S&P Global revised its outlook for the company. OUTLOOK NEGATIVE: Late Monday, rating agency S&P Global said in a note that U.S. Steel's recent decision to fund an investment in Arkansas-based Big River Steel with 100% debt "could stretch adjusted debt leverage above our threshold for a downgrade during 2019 or 2020 if market conditions remain weak." The rating agency revised its outlook for U.S. Steel to negative based on the steel-makers "reliance on improved market conditions to maintain steady debt levels during the buildout of the Mon Valley casting and rolling project." Big River CEO Dave Stickler commented, "U.S. Steel's decision to partner with us is a decisive vote of confidence in our company, our vision and our people... We have always called ourselves a technology company that just happens to make steel." TRADE WAR CASUALTY: According to a recent report from Bloomberg, Bayou Steel Group, located near New Orleans, has filed for bankruptcy protection after a lack of liquidity led to a default on its senior secured debt. John Bel Edwards, the Governor of Louisiana, said "While Bayou Steel has not given any specific reason for the closure, we know that this company, which uses recycled scrap metal that is largely imported, is particularly vulnerable to tariffs." PRICE ACTION: Shares of United States Steel are down almost 9% to $10.89 per share in afternoon trading. OTHERS TO WATCH: Other companies in the steel sector are also trading lower, including AK Steel (AKS), Steel Dynamics (STLD), Nucor (NUE), and Cleveland-Cliffs (CLF).

14:07 EDT WW slide deepens day after Novo Nordisk strikes weight management pact with Noom - Shares of WW International (WW), the company formerly known as Weight Watchers, have been bleeding lower throughout today's session after drugmaker Novo Nordisk (NVO) and behavior management company Noom announced a collaboration yesterday. Novo and Noom announced on Tuesday morning that they will collaborate on digital health solutions focusing on weight management and education following a "successful" 8-month pilot that combined Noom's behavior change programs with Novo Nordisk's "more than 95 years of experience in helping people living with chronic diseases." Their collaboration will initially make solutions for behavior change and education available to people with obesity in the U.S., Novo Nordisk and Noom said. In afternoon trading, WW International shares have fallen $5.06, or 13.5%, to $32.28.

13:57 EDT FireEye jumps 4% to $13.72 after BI report of potential sale

13:55 EDT FireEye trading halted, volatility trading pause

13:28 EDT Progenics shareholder Velan calls Lantheus transaction 'value-destructive' - Velan Capital, which identifies itself as one of the largest stockholders of Progenics Pharmaceuticals (PGNX), responded to the decision by the Progenics board of directors to enter into a "value-destructive" all-stock transaction with Lantheus (LNTH). Velan stated in part in its open letter: "We believe Progenics' announcement today to sell the company to Lantheus substantially undervalues the company and is a transparent and shameful maneuver attempting to prevent the voices of stockholders from being fairly heard. Velan is appalled that the Board would so egregiously attempt to shirk its fiduciary duties by approving a transaction to sell the company at such a massive discount...[CEO Mark Baker] now appears to be pursuing a buyout, in our view, to avoid being held accountable by stockholders and potentially being replaced with a more capable leadership team. This most recent act of desperation solidifies our belief that substantial Board reconstitution is necessary at Progenics and we are committed to proceeding with our consent solicitation to add five highly-qualified, fully-independent directors before the Lantheus transaction moves forward."

12:03 EDT Aerojet Rocketdyne awarded nearly $19M contract by Missile Defense Agency - Aerojet Rocketdyne has been awarded a contract worth up to nearly $19M by the Missile Defense Agency to mature Axial Upper Stage component technologies and analytical tools to demonstrate component, material and architecture solutions to support future hypersonic development efforts.

12:02 EDT EEOC sues Walmart for discriminatory hiring practices at Oklahoma facility - Wal-Mart Stores East, LP violated federal law when it declined a job applicant the opportunity to take a pre-hiring physical assessment test and did not hire the applicant, the U.S. Equal Employment Opportunity Commission charged in a lawsuit. According to the lawsuit, the applicant, who was born with her right arm ending at the elbow, sought a Freight Handler position at Wal-Mart's Distribution Center in Ochelata, Okla. She had warehouse experience lifting items up to 200 pounds without the use of a prosthetic. The applicant successfully interviewed for the position and watched a video demonstrating the physical assessment test. When asked whether she needed an accommodation to take the assessment, the applicant declined. Wal-Mart nonetheless did not allow her to take the assessment without a prosthetic. Such alleged conduct violates the Americans with Disabilities Act, as amended. After first attempting to reach a pre-litigation settlement through its conciliation process, the EEOC filed suit in U.S. District Court for the Northern District of Oklahoma. The agency seeks monetary damages, training on anti-discrimination laws, posting of anti-discrimination notices at the worksite, and other injunctive relief.

12:00 EDT Britannia Bulk rises 7.1% - Britannia Bulk is up 7.1%, or 41c to $6.16.

12:00 EDT ProShares Trust Ultra VIX Short Term Futures ETF rises 9.4% - ProShares Trust Ultra VIX Short Term Futures ETF is up 9.4%, or $2.60 to $30.22.

11:50 EDT Clorox shares down 2% as company issues guidance at investor day meeting

11:31 EDT AMD, Microsoft announce new 15-inch Microsoft Surface Laptop 3 - AMD (AMD) and Microsoft (MSFT) announced the first-ever 15-inch Microsoft Surface Laptop powered by new AMD Ryzen Microsoft Surface Edition processors. The companies said, "A significant, multi-year co-engineering program between AMD and Microsoft at the silicon, platform, and software levels created this 15" Microsoft Surface Laptop 3 with a perfect balance of performance, battery life, and sleek and lightweight design. Combining world-class compute and graphics performance with a fully optimized, rearchitected system software stack including AMD Radeon FreeSync display technology, Microsoft Surface Laptop 3 is designed for creative professionals, students, gamers on the go, and business users who value the large screen experience alongside portability. The custom AMD Ryzen Microsoft Surface Edition processors and optimized software highlight the latest example in the multi-year collaboration between AMD and Microsoft, first established more than a decade ago for the Microsoft Xbox and now spanning from Azure to Surface to xCloud and Project Scarlett."

11:22 EDT Lennar: Investor interest in new single-family rentals is 'intense'

11:13 EDT Lennar boosts FY19 home delivery target to 51,000 homes from 50,000

11:10 EDT Four Corners Property Trust acquires outparcel portfolio for $46.4M - Four Corners Property Trust announced that it has signed a definitive agreement for the purchase of 24 outparcel properties from Brookfield Properties, for a purchase price of approximately $46.4M. This transaction was priced at a capitalization rate consistent with our investment thresholds and past transactions. The portfolio includes 14 restaurant properties as well as 10 properties operating in other retail sectors. "Brookfield has been a fantastic partner for FCPT in the past as we've worked on smaller transactions and we look forward to focusing our attention on this new portfolio," said Bill Lenehan, CEO of FCPT. "This portfolio is consistent with our outparcel strategy of acquiring diverse brands in the restaurant and retail sectors with strong operators and low rent levels."

11:04 EDT Lennar says housing market continued to strengthen in Q3 - Comments taken from the Q3 earnings conference call.

10:40 EDT Agilent receives approval for first PD-L1 companion diagnostic in China - Agilent Technologies (A) announced that the National Medical Products Administration, formerly the China Food and Drug Administration, has approved its PD-L1 IHC 22C3 pharmDx assay for use in China. The assay is now approved as a companion diagnostic to identify patients with locally advanced or metastatic non-small cell lung cancer whose tumors express PD-L1 for first-line treatment with single-agent KEYTRUDA, an anti-PD-1 therapy manufactured by Merck & Co (MRK) in Kenilworth, NJ. PD-L1 IHC 22C3 pharmDx is the first and only NMPA-approved companion diagnostic that has been clinically validated to aid in the identification of NSCLC patients for treatment with KEYTRUDA.

10:08 EDT WTO arbitrator says U.S. may take countermeasures against EU of up to $7.5B/year - On October 2, a WTO arbitrator issued its decision on the level of countermeasures the United States may request with respect to the European Union and certain EU member states in "European Communities and Certain member States - Measures Affecting Trade in Large Civil Aircraft" The WTO announced that an arbitrator determined that the level of countermeasures "commensurate with the degree and nature of the adverse effects determined to exist", in the December 2011-2013 reference period, which was the same reference period used in the compliance proceedings, within the meaning of Article 7.10 of the SCM Agreement, amounts to $7.496B per annum. Therefore, the arbitrator concluded that the United States may request authorization from the DSB to take countermeasures with respect to the European Union and certain member States at a level not exceeding, in total, $7.496B annually. These countermeasures may take the form of suspension of tariff concessions and related obligations under the GATT 1994, and/or suspension of horizontal or sectoral commitments and obligations contained in the United States' services schedule with regard to all services defined in the Services Sectoral Classification List, except for financial services, the WTO said. Reference Link

10:02 EDT WWE down 6% ahead of AEW premiere tonight - Shares of WWE, the owner and operator of a series of wrestling properties including the WWE Network, is down 6% in early trading to $66.96 per share ahead of tonight's premiere on TNT of a new competitor, All Elite Wrestling. Reference Link

10:01 EDT Humana announces Medicare expansion in New Jersey - Humana is expanding health plan choices for Medicare beneficiaries in New Jersey by more than doubling the number of counties in which Humana Medicare Advantage plans are offered in the state. In another milestone, the company also is introducing an HMO plan in New Jersey for the first time. "Humana is proud to be able to reach additional New Jerseyans by offering Medicare Advantage plans in a total of 13 counties across the state for coverage starting in 2020," said Rich Vollmer, Humana Senior Vice President and Medicare North Division Leader. "We're also excited to broaden our plan options by introducing an HMO plan in New Jersey as well. Humana's investment in the state reflects our deep commitment to helping New Jerseyans achieve better health and well-being." For the first time, residents of seven New Jersey counties - Hunterdon, Somerset, Sussex, and Warren counties in Northern New Jersey; and Cumberland, Mercer, and Salem counties in Southern New Jersey - can select a Humana Choice Preferred Provider Organization Medicare Advantage plan during this year's Medicare Advantage and Prescription Drug Plan Annual Election Period, or AEP. The AEP runs from Oct. 15 through Dec. 7, 2019, for plan coverage taking effect Jan. 1, 2020. Humana also will continue to offer Medicare Advantage plans in six other counties - Bergen, Hudson, and Morris counties in Northern New Jersey; and Burlington, Camden, and Gloucester counties in Southern New Jersey - where Humana originated its Medicare Advantage presence in the state last year.

10:00 EDT ProShares Trust Ultra VIX Short Term Futures ETF rises 6.6% - ProShares Trust Ultra VIX Short Term Futures ETF is up 6.6%, or $1.82 to $29.44.

09:56 EDT UBS fined $2M by FINRA for misrepresenting tax status of interest payments - The Financial Industry Regulatory Authority announced it has censured and fined UBS Financial Services $2M for the bank's "repeated failures in timely addressing municipal short positions and in inaccurately representing the tax status of thousands of interest payments to customers." FINRA also required UBS to pay restitution to customers who may have incurred any increased state tax liabilities, to pay the Internal Revenue Service to relieve customers of any additional federal income tax owed, and to certify within 90 days that the firm has taken appropriate corrective measures.

09:47 EDT Borr Drilling falls -6.4% - Borr Drilling is down -6.4%, or -32c to $4.70.

09:47 EDT United Natural Foods falls -26.8% - United Natural Foods is down -26.8%, or -$2.97 to $8.10.

09:47 EDT ProShares Trust Ultra VIX Short Term Futures ETF rises 5.2% - ProShares Trust Ultra VIX Short Term Futures ETF is up 5.2%, or $1.45 to $29.07.

09:33 EDT Assured Guaranty 'does not support' Puerto Rico Oversight Board's proposed plan - Assured Guaranty released the following statement regarding the Financial Oversight & Management Board's Plan of Adjustment: "Assured Guaranty does not support the Oversight Board's proposed Plan, which is premised on a number of terms that Assured Guaranty believes violate Puerto Rico law, its constitution and PROMESA. The Plan also ignores the rule of law on which our society and financial systems rely, and constitutional liens and priorities. The Plan was developed in the absence of consensual discussions with the island's long-term and largest creditors and is based at its core on a Plan Support Agreement whose signatories represent only a small fraction of the outstanding debt it purports to restructure. The Oversight Board has repeatedly produced fiscal plans without appropriate input from the island's long-term creditors, based on unrealistic and inaccurate financial assumptions and projections. These actions in Assured Guaranty's view have cost the island hundreds of millions of dollars in litigation fees and time wasted. Assured Guaranty believes by disregarding basic tenets of PROMESA, Puerto Rico law and the U.S. and Puerto Rico constitutions, the Oversight Board has violated the explicit terms of the Commonwealth's general obligation bonds and special revenue bonds and undermined the underpinnings of the U.S. municipal bond market, potentially raising the cost of infrastructure development nationwide. An end to the Puerto Rico debt crisis is in sight, one that can reopen Puerto Rico's access to the capital market and encourage investment, but Assured Guaranty believes that solution needs to be driven by consensual resolutions and accurate financial data, and not by attempting a cramdown on investors who have supported the island for decades. Continuing with the Oversight Board's current approach, in Assured Guaranty's view, will not restore capital market access for Puerto Rico or ensure a solid and stable economic future for the island and its residents."

09:18 EDT Zynex reports 95% y-o-y growth in orders for Q3 - Zynex reported 95% year over year order growth for Q3. Orders in Q3 grew 95% compared to 3Q18 and 30% above 2Q19. In 2Q19, orders grew 65% year-over-year.

09:16 EDT Ford reports Q3 van sales 65,288, Q3 Expedition sales up 48%

09:15 EDT Andersons trading resumes

09:12 EDT Anomali, Symantec announce strategic partnership - Anomali and Symantec announced a strategic partnership to meet global demand for threat intelligence-driven solutions. The partnership expands availability of innovations that harness threat data, information and intelligence to drive effective cybersecurity decisions that strengthen defensives and reduce risk.

09:10 EDT Immuron announces funding of research agreement with NMRC - Immuron Limited announced the funding of a new research agreement with the Naval Medical Research Center, Silver Spring, MD, USA. The focus of this new agreement will be to develop a combined Campylobacter and enterotoxigenic E. coli-specific anti-microbial preventative for clinical evaluation. Under this agreement, Immuron and NMRC will be collaborating on the manufacture and evaluation of the new product designed to protect against travelers' diarrhea caused by Campylobacter and ETEC pathogens. The protective efficacy of the product will be tested utilizing two controlled human infection-model clinical trials, with one trial focusing on the ability of the hyperimmune product to protect volunteers against moderate to severe campylobacteriosis, and the second trial focusing on ETEC infections.

09:09 EDT Flexion partners with former Yankees outfielder Chris Dickerson for OA awareness - Flexion Therapeutics is teaming up with Chris Dickerson, a former New York Yankees outfielder and member of the 2011 and 2012 playoff teams, to raise awareness of the impact of osteoarthritis. Introduced at the start of baseball's postseason, the awareness effort highlights Chris' journey as a professional athlete and parent living with OA knee pain. A degenerative joint disease, OA affects more than 30 million adults living in the U.S. and accounts for more than $185B in annual expenditures.

09:05 EDT Yext and Trustpilot integrate review management platform - Yext announced a new global integration with Trustpilot, an independent platform for companies to build trust with consumers, that enables Yext customers with Trustpilot accounts to manage location-based reviews directly in the Yext platform. Businesses can now log in to the Yext platform to monitor and respond to their Trustpilot reviews in real time, in the same place they manage reviews from other channels.

09:03 EDT Rafael Pharmaceuticals appoints Wendy McDermott as chief people officer - Rafael Pharmaceuticals (RFL) announced the appointment of Wendy McDermott as chief people officer. McDermott joins Rafael from Sanofi (SNY), where she served as VP of HR The newly created position is indicative of the Company's dedication to growth and further development of talent and company culture.

09:01 EDT Tecogen obtains first order for new Tecofrost package - Tecogen announced the sale of a Tecofrost ammonia refrigeration system for an ice skating facility located in Massachusetts. It is the first Tecofrost sale since the product was re-introduced earlier in the year and includes Tecogen's Ultera emission technology. The system will provide cooling for ice making, with waste heat recovery used for dehumidification, ice resurfacing, domestic hot water, and space heat. "Many skating rinks rely on industrial refrigeration systems to maintain a professional quality ice surface," noted Stephen Lafaille, Director of Business Development at Tecogen. "Tecofrost is the only gas engine driven ammonia refrigeration system that is a drop-in replacement for electric systems and associated high operating costs. In addition to the reduced electric costs for the facility, the waste heat recovery of Tecofrost provides additional savings for building operators."

08:59 EDT Overstock.com Retail extends personalization technology to site - Overstock.com Retail announced the extension of its real-time personalization technology to its site. This integration builds on Overstock's recent announcement of an email experience that leveraged its proprietary technology LiveRex and Overstock's Asset Data Platform. The initiative aims to deliver a more engaging and relevant experience throughout every touchpoint of a customer's journey. Overstock has developed technology like LiveRex and OADP which is driven on machine learning algorithms to form a platform that enables real-time personalization.

08:57 EDT Andersons, Marathon Petroleum combine ethanol interests - The Andersons (ANDE) announced that it and Marathon Petroleum (MPC) have merged four ethanol entities with and into the new legal entity The Andersons Marathon Holdings. The ethanol facilities involved in the merger include those in Albion, Mich.; Clymers, Ind.; and Greenville, Ohio, which were all perviously jointly owned by The Andersons and Marathon Petroleum; and The Andersons' wholly-owned ethanol facility in Denison, Iowa. Effective October 1, The Andersons and Marathon Petroleum own 50.1% and 49.9% of TAMH equity, respectively. The transaction will result in the consolidation of TAMH's results in The Andersons' financial statements. In conjunction with the merger agreement, TAMH has entered into several new long-term services agreements with The Andersons. Under those agreements, The Andersons will continue to operate the four plants, buy corn, market ethanol and other coproducts and manage risk for TAMH. The merger will result in a step-up in the book basis of the Albion, Clymers and Greenville assets and a sizable one-time, noncash gain to The Andersons in the fourth quarter. The asset step-up will also result in higher depreciation expense. The amounts of both the gain and the additional depreciation are still being determined. In addition, the debt previously held by the separate entities was refinanced using a new $200M TAMH credit facility.

08:49 EDT Agraflora Organics provides update on Delta Greenhouse upgrades - AgraFlora Organics International provides a summary of the Phase 1 Delta Greenhouse Complex infrastructure upgrades completed to date. AgraFlora has deployed over C$30,000,000 in plant, property and equipment expenditures at its Phase 1 Delta Greenhouse Complex retrofit in preparation for receipt of its standard cultivation license from Health Canada. AgraFlora's Delta Greenhouse Complex is second in size and magnitude only to the Smiths Falls facility owned by Canopy Growth. By way of additional comparison, AgraFlora's Delta Facility is 100,000 square feet larger than Aurora Cannabis Inc.'s facility in Edmonton, Alberta and it is also more than 700,000 square feet larger than the current size of the Leamington facility owned by Aphria. AgraFlora's internal forecasts indicate that upon receipt of its aforementioned standard cultivation licence from Health Canada, the Company will become the fourth-largest licensed producer in Canada by 2020 financed production metrics; strategically positioned in close proximity to Canada's largest cannabis economic centres: Toronto and Vancouver. The Company plans to commence Phase 2 of the Delta Greenhouse Complex retrofit in December of 2019, which will include: 10 flower rooms with over one million square feet of canopy; 40,000 square feet of EU-GMP postharvest/processing space; Equipped with ozone-rich drying rooms; Installation of an industrial kitchen; and, Workflow design to include commercial C02 and Ethanol extraction capabilities.

08:44 EDT Toll Brothers Apartment Living, Carlyle Group launch JV to develop Osprey - Toll Brothers (TOL) and an affiliate of global investment firm The Carlyle Group (CG) have announced the formation of a new joint venture to develop Osprey, a 320-unit luxury apartment community in Atlanta's West Midtown neighborhood. The joint venture has secured a construction loan facility from BB&T Real Estate Funding LLC, serving as administrative agent, and Comerica Bank. The debt and equity financing were arranged by Toll Brothers' in-house Finance Department. Toll Brothers Apartment Living will manage the development, marketing, leasing and property management of Osprey. Osprey is located on a 2.07-acre parcel within a mixed-use community in the vibrant West Midtown neighborhood of Atlanta. Leasing and first move-ins are projected for early 2020. Osprey will be one of the first luxury rental projects to deliver in the epicenter of West Midtown. Carlyle's equity for this investment came from the Carlyle Realty Partners VIII fund. Financial terms of the transaction were not disclosed.

08:41 EDT CTBH announces remarketing of $11M of revenue bonds for Casella Waste - CTBH Partners announced the closing of $11M tax-exempt solid waste industrial revenue bonds for its client, Casella Waste Systems. As financial advisor to the borrower, CTBH represented Casella in the remarketing of its Business Finance Authority of the State of New Hampshire Solid Waste Disposal Revenue Bonds Series 2013. The Bonds bear interest at a rate of 2.95% from October 1, 2019 until the final maturity of April 1, 2029. The Bonds have been rated "B" by S&P Global Ratings and "B2" by Moody's Investor Service. BofA Securities, Inc. served as the remarketing agent on the transaction. The Bonds were originally issued on April 4, 2013. The fixed term interest rate period under which the Bonds were previously issued expired. Accordingly, the Bonds were remarketed on October 1, 2019. The Bonds are payable solely from amounts received from Casella under the indenture and are not a general obligation of the Authority, nor are they a debt or pledge of the faith and credit of the State of New Hampshire.

08:38 EDT Kitov Pharmaceuticals appoints Eric Rowinsky as chairman of board - Kitov Pharma announced the appointment of Eric Rowinsky, M.D., as chairman of its board of directors. Rowinsky joins Kitov's Board with extensive cancer research and drug development experience, oncology and corporate strategy expertise, and broad scientific and medical knowledge.

08:34 EDT ANI Pharmaceuticals launches generic equivalent of Aggrenox - ANI Pharmaceuticals has launched Aspirin and Extended Release Dipyridamole Capsules, the generic equivalent of Aggrenox. ANI acquired the rights to launch this drug in an acquisition executed in 2018. ANI estimates that the current annual U.S. market for Aspirin and Extended Release Dipyridamole Capsules is approximately $80M. There are currently six suppliers of this drug in the U.S. market. Aspirin and extended-release dipyridamole capsules are indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis.

08:33 EDT Walmart suspends sales of all over the counter ranitidine products - Walmart is suspending the sale of all over the counter ranitidine products in stores, clubs and online, including Zantac, Equate and Member's Mark brands. The company is taking this action after closely monitoring the recent product alert from the FDA that ranitidine products may contain a low level of nitrosodimethylamine. Customers who purchased these products may return them to Walmart or Sam's Club for a refund.

08:33 EDT RigNet executive team members meet with FCC commissioner Brendan Carr - RigNet (RNET) had members of its executive team including CEO, Steven Pickett, CIO/CTO, Brendan Sullivan, and SVP, of Government Services, Jamie Barnett Rear Admiral USN along with representatives from T-Mobile (TMUS) met with Commissioner Carr during a tour of Valaris' (VAL) Gulf Copper facility, including touring a state-of-the-art rig in Galveston, TX. During the tour, the company representatives informed Commissioner Carr about the new 4G LTE and 5G-capable network launched across more than 60,000 square miles of the Gulf of Mexico. This network now connects offshore workers, vessels and critical infrastructure in an area larger than the state of Florida.

08:30 EDT Savara trading resumes

08:26 EDT Paradise Development urges HBC 'to protect interests of minority shareholders' - Paradise Developments, a long-term shareholder of HBC, announced that it has delivered a letter to the Special Committee of the Company's Board of Directors related to the non-binding proposal by a group of HBC shareholders to take the company private at $9.45 per share. The letter read, in part: "We understand that you are currently evaluating the privatization of the Hudson's Bay Company at a price of $9.45 per share in cash from a group of HBC shareholders including individuals and entities related to, or affiliated with, Richard A. Baker, Governor and Executive Chairman of HBC; Rhone Capital L.L.C.; WeWork Property Advisors; Hanover Investments S.A.; and Abrams Capital Management. The group disclosed that they collectively own approximately 57% of the outstanding common shares of HBC on an as-converted basis. In doing so, we trust that you will take seriously your duty of care and your obligation to protect the interests of minority shareholders under Multilateral Instrument 61-101. We urge you to take the following steps to ensure that minority shareholders receive fair value for their investment: 1. Have J.P. Morgan Securities as financial advisor, Centerview Partners LLC as special advisor prepare or obtain an appraisal of the Company's owned real estate, and 2. Ensure that Advisors' valuation of the Company incorporates the imminent and material value and benefits which can be realized through development, joint ventures and potential spin-off of the real estate assets of the Company, whereby ALL shareholders can realize the maximum value they are entitled to...As you no doubt are aware, HBC's owned real estate is incredibly valuable relative to its current market cap and enterprise value. At $9.45 per share, the Insider Offer doesn't come close to cover the value of HBC's real estate and any of its upside potential, which may be realized through development, joint ventures and spin-off scenarios. Therefore, we fail to see how the Insider Offer can be viewed as being anywhere close to fair value. We urge you to have the Advisers prepare or otherwise obtain an appraisal of HBC's owned real estate. In conclusion, it is incumbent on you, in discharging your duty of care and your obligation to protect minority shareholders under MI 61-101, to ensure that the Advisers valuation of HBC includes an assessment of the market value of its real estate. Once the Company is properly valued, it is clear that the Insider Offer does not even come close to providing fair value to minority shareholders. Therefore, we urge you to either negotiate a fair price or to recommend that the Insider Offer be rejected."

08:21 EDT Soleno says DSMB recommends continuation of Phase III DESTINY PWS trial - Soleno Therapeutics announced that the Data Safety Monitoring Board has, for the second time, recommended the continuation without modification of the Company's Phase III trial in Prader-Willi Syndrome patients, DESTINY PWS. The outcome of this second planned meeting was based on the review of data from more than 50% of patients enrolled and treated. "We are pleased to again receive the DSMB's recommendation to continue the Phase III trial as planned and without modification, which provides ongoing support of DCCR's safety profile," said CEO Anish Bhatnagar. "Enrollment in DESTINY PWS remains on track for the availability of top-line data in the first half of 2020." DESTINY PWS is a Phase III, randomized, double-blind, placebo-controlled study of once daily oral administration of DCCR versus placebo in approximately 100 patients with a confirmed diagnosis of PWS. The primary endpoint is change from baseline hyperphagia score at Week 13. Patients who complete DESTINY PWS have the option to enroll into C602, the open-label safety extension study.

08:15 EDT Predictive Oncology sells ten STREAMWAY systems to teaching hospital - Predictive Oncology has completed the sale of ten STREAMWAY systems to a teaching and research hospital in upstate New York. The sale surpasses the company's largest single hospital sale to date and is expected to generate 6000 procedures annually.

08:12 EDT Orion Group announces contract awards of approximately $14M - Orion Group announced contract awards totaling approximately $14M. The company's Marine segment has been awarded two contracts from the US Army Corps of Engineers following successful competitive bids to provide dredging services along the Texas Gulf Coast. The first project calls for dredging of the Gulf Intracoastal Waterway, or GIWW, from Freeport Harbor to the upper Matagorda Bay in Brazoria and Matagorda counties. The work is valued at approximately $6.6M and is expected to be completed in Q3 of 2020. The second award, with a value of approximately $7.8M, will see Orion dredge the GIWW between Corpus Christi and Port Isabel and the channel to Harlingen in Kennedy, Willacy and Cameron counties. This project is expected to be completed by Q4 of 2020. Both projects also include options at the Corps' request for additional work that may increase the scope of work and contract value.

08:11 EDT PTC Therapeutics reports results of risdiplam in spinal muscular atrophy - PTC Therapeutics (PTCT) announced data demonstrating the 'ongoing benefit' of risdiplam for the treatment of all types of spinal muscular atrophy, or SMA, at the 24th International Annual Congress of the World Muscle Society. The SMA program is a collaboration between PTC, the SMA Foundation, and Roche (RHHBY). Data from Part 1 of the Firefish clinical trial demonstrated that after 16 months of treatment, 82% of high-dose patients had a CHOP-INTEND score greater than or equal to 40. 86% of all infants were event-free after receiving risdiplam for 16 months. The primary objective of Firefish Part 1 was to assess the safety profile of risdiplam in infants and determine the dose for Part 2. In patients in Part 1 of the SUNFISH clinical trial, risdiplam treatment led to a median two-fold increase in blood SMN protein levels after four weeks of treatment, sustained for at least 12 months. In the natural history cohort, patients did not experience any change in SMN protein levels over the same period. Patients receiving risdiplam in Sunfish Part 1 showed a clinically meaningful increase in total MFM32 score. Data from 45 patients in the Jewelfish trial demonstrated a sustained, greater than two-fold increase in median SMN protein versus baseline over 12 months of treatment. Risdiplam has been well tolerated at all dose levels and in all clinical studies. To date, there have been no drug-related safety findings leading to withdrawal from any study.

08:10 EDT Sodexo renews partnership in organization of Rugby World Cup - Sodexo is partnering with World Rugby in the organization of this year's World Cup, taking place in Japan. Sodexo has renewed its partnership in the organization of the Rugby World Cup, which this year is expanding to the design and marketing of all hospitality services across the twelve stadiums where games will take place. The company has joined forces with a well-respected local partner, JTB to provide services that fully respect and draw from local customs.

08:08 EDT Inseego appoints Wendy Caceres as CMO - Inseego (INSG) announced the appointment of Wendy Caceres as chief marketing officer, or CMO, reporting directly to chairman and CEO Dan Mondor. Most recently, Caceres was worldwide head of enterprise marketing for Amazon (AMZN) Web Services, or AWS. She led product marketing, sales enablement, customer advocacy and adoption initiatives for the AWS platform and Amazon's people-based services. In addition to leading a large U.S.-based team, she had oversight of AWS enterprise marketing staff across Amazon's geographies worldwide and led global enterprise positioning and go-to-market strategies. In this role, she was responsible for the development of marketing campaigns and sales enablement programs.

08:07 EDT Aytu BioScience, Validus announce ZolpiMist co-promotion agreement - Aytu BioScience and Validus Pharmaceuticals LLC, a privately-held specialty pharmaceutical company focused on acquiring, reformulating, and marketing prescription products in specialty therapeutic areas, announced the signing of a co-promotion agreement to exclusively commercialize ZolpiMist to psychiatrists in the United States. For the twelve months ending August 2019, U.S. psychiatrists wrote over 2.7 million zolpidem tartrate prescriptions, representing $163M in wholesale revenue. This represents Aytu's third announced product co-promotion and has expanded Natesto, Tuzistra XR, and ZolpiMist promotional efforts to over 100 sales representatives nationwide. Validus began ZolpiMist promotion October 1, 2019. Through this co-promotion, Validus gains exclusive promotional rights to ZolpiMist to psychiatrists and will receive a fixed percentage commission payment based on total psychiatrist prescriptions written. The agreement term is three years and allows for Validus' expansion of promotion to all U.S. psychiatrists. Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "Validus is an ideal partner with which to expand our promotional efforts for ZolpiMist. Their established commercial capability and strong relationships with psychiatrists, who are prolific prescribers of sleep aids, make Validus an excellent fit to grow ZolpiMist prescriptions in a specialty we don't currently reach. Further, this partnership enables our sales force to focus on primary care and provides for promotion by an experienced sales team in this high-prescribing specialty in key markets around the country."

08:04 EDT Durect's NDA resubmission for Posimir to be discussed by FDA Advisory Comittee - Durect's Class 2 NDA resubmission for Posimir will be discussed at a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee or AADPAC. The meeting is tentatively scheduled for January 16, 2020. The FDA had previously assigned a user fee goal date of December 27, 2019; a new user fee goal date has not been assigned. Posimir is the company's investigational post-operative pain relief depot product that utilizes Durect's patented Saber technology. Posimir is designed to be administered directly into the surgical site to deliver bupivacaine for up to three days after surgery. Posimir has not been approved by the FDA for marketing in the U.S. for any indication.

08:03 EDT Camber Energy Sub Lineal regains major legacy customer lost by prior owner - Camber Energy announced that its recently acquired subsidiary Lineal Industries has regained a major legacy customer lost by its prior owners before the purchase of the company by Lineal Star Holdings, LLC in 2018. The customer is one of the largest wholesale distributors of refined petroleum products in the USA, with strategically located terminals in the Northeast, MidAtlantic and Southeast markets, the company said in a statement. Previously one of Lineal's most important clients, the prior Lineal owners pursued larger, more complex pipeline projects in lieu of the customary long-term maintenance projects Lineal Industries built its reputation on. Lineal Industries has now been awarded a number of pipeline integrity projects by the re-acquired customer, which reopens the company's opportunity to provide long-term maintenance and capital project services.

07:55 EDT Biogen announces publication of data from NURTURE study with SPINRAZA - Biogen announced that the journal Neuromuscular Disorders has published data from NURTURE, the first study investigating a treatment targeting the underlying cause of spinal muscular atrophy in infants treated pre-symptomatically. Data from the NURTURE study demonstrated that infants who initiated treatment with SPINRAZA prior to the onset of clinical symptoms attained unparalleled results compared to the natural history of the disease. As of March 2019 all participants were alive, without the need for permanent ventilation and experienced continuous improvements with the majority achieving motor milestones in timelines consistent with normal development. The results also demonstrated durability of effect with children making progress throughout the study. NURTURE is an ongoing, Phase 2, open-label study of 25 infants with the genetic diagnosis of SMA who received their first dose of SPINRAZA in the pre-symptomatic stage and before six weeks old. The study, conducted at 15 sites in seven countries, has results up to 45.4 months. When compared with the natural history of the disease, the results are dramatic in their impact on changing the course of SMA. As of March 2019 all infants in the study were 25 months or older, past the typical age of symptom onset for SMA Type 1 and Type 2, and were alive without the need for permanent ventilation. In comparison to the natural history of SMA, many of these infants would likely have passed away or require permanent ventilation on average by 13.5 months. In both the children with two and three copies of SMN2, treatment with SPINRAZA demonstrated rapid onset of improvement and durability of effect with their mean Children's Hospital of Pennsylvania Infant Test of Neuromuscular Disorders score of motor function reaching the maximum mean score of 64 for all participants with three copies of SMN2 and a mean of 62.1 for those with two copies of SMN2. Additional highlights include: The majority of study participants achieved motor milestones in timeframes consistent with the World Health Organization standards, with 100 percent sitting independently and 88 percent walking independently. Hammersmith Infant Neurologic Examination, Section 2 development of motor function scores increased for all participants with the mean score for both those with two or three SMN2 copies approaching the maximum score of 26 points at the last assessment. SPINRAZA demonstrated longer term efficacy up to nearly four years, with participants continuing to make progress. SPINRAZA was well-tolerated with no new safety concerns identified after up to nearly four years of treatment.

07:53 EDT Primoris announces electric T&D award valued at $15M - Primoris Services Corporation announced an extension of an existing Master Service Agreement with a major utility customer with a combined two year anticipated value of $15M. The contract was secured by Primoris T&D, part of the Transmission & Distribution segment. This contract was signed in the third quarter of 2019. The award is a two year agreement for services in North Carolina and South Carolina. Work performed under the MSA encompasses continuing replacement of underground electrical cable. It is estimated that the MSA will generate approximately $7.5M per year. While the agreement does not obligate the customer to award Primoris a specific dollar amount, our discussions and history with the customer form the basis for our anticipated value.

07:52 EDT Vericel, MediWound announces initiation of NexoBrid expanded access protocol - Vericel Corporation (VCEL) and MediWound (MDWD) announced initiation of the NexoBrid expanded access treatment protocol to treat burn patients with deep partial- and full-thickness burns in the U.S. during the preparation and review of the NexoBrid Biologics License Application. NEXT is an open-label, single-arm treatment protocol which allows for the treatment of up to 150 burn patients with deep partial- and full-thickness thermal burns up to 30% of total body surface area. NEXT has been designed to be consistent with current real-life burn treatment practices in the U.S. and up to 30 U.S. burn centers will participate. The increased number of burn centers trained and familiar with NexoBrid prior to FDA approval will improve national readiness for potential burn mass casualty events. To further promote national readiness, the FDA has agreed that in the event of a burn mass casualty event that is not a nationally declared emergency, additional patients could be treated under the NEXT treatment protocol.

07:50 EDT T2 Biosystems to showcase rapid diagnostics at IDWeek 2019 - T2 Biosystems announced that it will showcase its latest rapid diagnostics for the detection of sepsis-causing pathogens, directly from whole blood, at IDWeek 2019 in Washington, D.C. from October 2 to 6. At the conference - which brings together professionals in the infectious disease industry to meet, share experiences and develop collaborations - the Company will host daily in-booth presentations at booth 1026 that will demonstrate the clinical value of its rapid diagnostics through real-world, clinical case studies. Additionally, Sandy Estrada, PharmD, BCPS, Vice President of Medical Affairs at T2 Biosystems, will serve as a panelist in a session titled, "Rapid Diagnostics and Resistance: Making Sense of Now and the Future Part 2 - Mechanism-based Diagnostics for AMR." The T2Bacteria and T2Candida Panels - the only FDA-cleared panels that can detect sepsis-causing pathogens directly from a patient's blood sample, without the need to wait for a blood culture - will be available for demonstration in the booth. Both panels utilize the same T2Dx Instrument and can detect sepsis-causing pathogens in the bloodstream in three to five hours. Additionally, the T2Bacteria and T2Candida Panels will be highlighted in seven poster presentations throughout the conference in addition to an eighth poster presentation from Jessica Snyder, PhD, from T2 Biosystems, titled, "Detection of Antibiotic Resistance Genes in Clinical Samples using T2 Magnetic Resonance," highlighting early study data generated with the T2Resistance Panel

07:48 EDT NextCure promotes Timothy Mayer to COO - NextCure announced the promotion of Timothy Mayer, Ph.D. from SVP, corporate development to COO. Mayer has extensive experience in the biopharmaceutical industry, including with antibody therapeutics, small molecule pharmaceuticals and molecular biology research tools.

07:42 EDT Overseas Shipholding announces delivery of two vessels - Overseas Shipholding announced that it has taken delivery of two 50,000 DWT class product and chemical tankers at Hyundai Mipo Dockyard. The tankers, named the Overseas Gulf Coast and Overseas Sun Coast, were built to comply with MARPOL Annex VI Regulation 13 Tier III standards regarding nitrogen oxide emissions within emission control areas. In addition, each vessel is fitted with an exhaust gas cleaning system, often referred to as a scrubber, to meet the standards of MARPOL Annex VI Regulation 14 standards regarding sulphur oxide emissions. The Overseas Gulf Coast and Overseas Sun Coast will be operating in the international market under the Marshall Islands flag, with both vessels having entered into one-year time charters. Following this initial contract period, OSG anticipates that the vessels will transition to operate under the U.S. flag.

07:42 EDT Axsome Therapeutics expects to report CONCERT trial results in Q4 - AXS-12 is Axsome's novel, oral, potent and highly selective norepinephrine reuptake inhibitor being developed for the treatment of narcolepsy. AXS-12 has been granted Orphan Drug Designation by the FDA for the treatment of narcolepsy. To date, 70% of the targeted number of patients have been randomized into the CONCERT Phase 2 trial of AXS-12 in patients with narcolepsy. Axsome remains on track to report topline results from the CONCERT trial in the fourth quarter of 2019.

07:40 EDT Axsome Therapeutics expects to file NDA for AXS-05 for MDD in 2H20 - Axsome Therapeutics will participate in the 2019 Cantor Global Healthcare Conference on Thursday, October 3, 2019. Herriot Tabuteau, MD, Axsome's CEO will participate in a fireside chat at 3:00 PM Eastern Time. The conference will be held at the InterContinental New York Barclay in New York, NY. Tabuteau will provide the following update on the Company's continued progress during the presentation: AXS-05: AXS-05 is Axsome's novel, oral, investigational NMDA receptor antagonist with multimodal activity being developed for the following indications: treatment resistant depression , major depressive disorder, Alzheimer's disease agitation, and smoking cessation. AXS-05 has been granted U.S. Food and Drug Administration Breakthrough Therapy designation for the treatment of MDD and Fast Track designations for the treatment of TRD and for the treatment of AD agitation. To date, approximately 75% of the targeted number of patients have been randomized into the GEMINI Phase 3 placebo-controlled trial of AXS-05 in MDD. Axsome remains on track to report topline efficacy results from both the GEMINI trial and the STRIDE-1 trial of AXS-05 in TRD in the fourth quarter of 2019. An NDA filing for AXS-05 in the treatment of MDD is targeted for the second half of 2020. To date, approximately 65% of the targeted number of patients have been randomized into the ADVANCE-1 Phase 2/3 trial of AXS-05 in agitation associated with Alzheimer's disease. Axsome continues to anticipate topline results from the ADVANCE-1 trial in the first half of 2020.

07:38 EDT Blackstone forms $2.9B joint venture to acquire 65% Great Wolf Resorts interest - Blackstone Real Estate Partners IX, an affiliate of Blackstone, and affiliates of Centerbridge announced that Blackstone is acquiring a 65% controlling interest in Great Wolf Resorts. Great Wolf is a owner and operator of family-oriented entertainment resorts, with 18 resorts around the country. As part of the transaction, Blackstone and Centerbridge will form a new $2.9B joint venture to own the company.

07:36 EDT Oracle to acquire CrowdTwist, terms not disclosed - Oracle announced it signed an agreement to acquire CrowdTwist, the leading cloud-native customer loyalty solution to empower brands to offer personalized customer experiences. The solution offers over 100 out-of-the-box engagement paths, providing rapid time-to-value for marketers to develop a more complete view of the customer. Upon the close of the acquisition, the CrowdTwist team will join the Oracle Customer Experience Cloud organization.

07:32 EDT Valeritas reduces long-term debt obligation - Valeritas Holdings announced the restructuring of a substantial portion of its outstanding long-term debt, reducing the total debt balance by an aggregate of $25M. Under the terms of the debt restructuring, $25M of Valeritas senior secured long-term debt held by CR Group affiliated funds and another creditor was exchanged for newly created Valeritas Series B Convertible Preferred Stock, the terms of which are disclosed in a Form 8-K to be filed with the SEC. The debt exchange reduces the outstanding balance of senior secured debt to approximately $17M. The debt restructuring is expected to save Valeritas approximately $8.0 million in cash interest expense payments through March 2022.

07:29 EDT Arvinas announces appointments to scientific advisory board - Arvinas announced that six new thought leaders will join the company's scientific advisory board. The new members are Tomasz Beer, M.D., F.A.C.P., Adam Boxer, M.D., Ph.D., Sara Courtneidge, Ph.D., Lennart Mucke, M.D., Benjamin Neel, M.D., Ph.D., and Lillian Siu, M.D. The Full Arvinas Scientific Advisory Board: Craig Crews is the Founder of Arvinas, as well as the John C. Malone Professor of Molecular, Cellular and Developmental Biology, Chemistry and Pharmacology at Yale University. Tomasz M. Beer serves as the Grover C. Bagby Endowed Chair for Prostate Cancer Research and is a Professor of Medicine for the Division of Hematology & Medical Oncology and Deputy Director of the Oregon Health & Science University Knight Cancer Institute. Adam L. Boxer is the Endowed Professor in Memory and Aging in the Department of Neurology at the University of California, San Francisco. Sara A. Courtneidge, Ph.D., is a Professor in the Department of Cell, Developmental & Cancer Biology, a member of the Knight Cancer Institute, and a member of the Center for Spatial Systems Biomedicine at Oregon Health & Science University. Benjamin G. Neel serves as a Professor of Medicine at NYU School of Medicine and Director of Perlmutter Cancer Center at NYU Langone Health. Lennart Mucke is the founding Director of the Gladstone Institute of Neurological Disease. Lillian L. Siu is a senior medical oncologist at the Princess Margaret Cancer Centre and a Professor of Medicine at the University of Toronto.

07:25 EDT Anavex receives U.S. patent for composition of matter covering ANAVEX 2-73 - Anavex Life Sciences announced that the United States Patent and Trademark Office granted U.S. Patent No. 10,426,754 to support Anavex's leading drug candidate, ANAVEX 2-73 for the treatment of Alzheimer's disease. Anavex's newest patent is expected to remain in force at least until 2037, not including any patent term extensions. It covers compositions of matter directed to crystalline ANAVEX 2-73, and methods of treating Alzheimer's disease using crystalline ANAVEX 2-73. ANAVEX 2-73 recently completed a successful Phase 2a clinical trial for Alzheimer's disease and is currently in clinical studies in a larger Phase 2b/3 study for Alzheimer's disease, among other studies. The '754 patent adds important coverage for crystalline ANAVEX 2-73 dosage forms for treating Alzheimer's disease.

07:20 EDT Amicus expects PROPEL study to support approval for a broad indication - The Company's strategy is to enhance the body of clinical data for AT-GAA in ongoing clinical studies, including the pivotal study to deliver this potential new therapy to as many people living with Pompe disease as soon as possible. Based on feedback from US and EU regulatory authorities, Amicus expects the PROPEL study to support approval for a broad indication, including ERT-switch and treatment-naive patients. Anticipated Pompe Milestones: Presentation of 24-month and Cohort 4 Phase 2 results at Amicus Analyst Day on October 10, 2019. Additional supportive studies, including an open-label study in pediatric patients. Full enrollment in Phase 3 PROPEL study in 2019. Advance agreed upon CMC requirements to support BLA. Publication of Phase 1/2 clinical results.

07:17 EDT Amicus presents ATB200-02 study data highlights from cohort 4 - A fourth cohort of six additional ERT-switch ambulatory patients was subsequently added to the study. At the time of the data analysis, five patients have available data at month 6. The last available timepoint includes all six patients after 3-15 months of treatment, with one subject at Month 3, two subjects at Month 6, two subjects at Month 12 and one subject at Month 15. Motor Function: Muscle function improved in 2/5 patients at month 6 and 4/6 patients at the last available time point: Historical data on 6MWT for the six patients showed an average decline of approximately 7 meters per year while on standard of care ERT prior to switching to AT-GAA, with 5/6 patients declining. After switching to AT-GAA, the patients in Cohort 4 showed mean increases of 24 meters at month 6 and 19 meters at their last available timepoint. 6MWT increased in 2/5 patients at month 6 and 4/6 patients at the last available time point. Other motor function tests generally showed mean improvements consistent with 6MWT distance at month 6 and at their last available timepoint. All patients showed improvements in strength testing from baseline to month 6 and at the last available timepoint, as measured by quantitative muscle testing and manual muscle testing. Pulmonary Function: Pulmonary function improved at month 6 and at the last available time point. After switching to AT-GAA, FVC increased in 5/6 patients at month 6 and 5/6 patients at the last available time point. Mean absolute change in FVC was +6.6% at month 6 and +5.2% at the last available time point. Overall, other pulmonary tests of maximal inspiratory pressure, a measure of inhalation, and maximal expiratory pressure, a measure of exhalation, were stable or increased in all patients at month and at the last available timepoint.

07:12 EDT Amicus announces additional results from Phase 1/2 study of AT-GAA - Amicus Therapeutics announced additional results from a global Phase 1/2 clinical study to investigate AT-GAA in adult patients with Pompe disease, an inherited lysosomal storage disorder caused by an enzyme deficiency that leads to accumulation of glycogen in cells. The U.S. Food and Drug Administration previously granted Breakthrough Therapy Designation to AT-GAA for the treatment of late onset Pompe disease based on clinical efficacy results this Phase 1/2 clinical study, including improvements in six-minute walk distance in late onset Pompe patients and comparison to natural history of treated patients. Patients treated with AT-GAA for 24 months showed persistent and durable effects on six-minute walk test distance and other measures of motor function and muscle strength, stability or increases in forced vital capacity, and reductions in biomarkers of muscle damage and disease substrate. Consistent with these 24-month results, positive impacts on the same measures of motor and pulmonary function and key biomarkers were also observed after 3-15 months of treatment in an additional group of six ambulatory ERT switch patients that had been on standard of care ERT for at least seven years prior to switching to AT-GAA. These clinical results are being featured at the 24th International Annual Congress of the World Muscle Society in an oral platform presentation.

07:09 EDT Twitter says experiencing outages across Twitter, TweetDeck - Twitter said via its Support team: "We've been experiencing outages across Twitter and TweetDeck. You might have had trouble Tweeting, getting notifications, or viewing DMs. We're currently working on a fix, and should be back to normal soon." Reference Link

07:07 EDT LiveXLive Media reaches 775,000 paid subscribers - LiveXLive Media announced select operational metrics for the first six months of FY20. The company achieved 775,000 paid subscribers as of September 30, up 95,000 YTD since April 1; with Monthly Active Users over 1.1 million as of September 30; livestreamed 19 music festivals and events during first half of FY20 versus 24 events livestreamed during the entire FY19; YTD livestreams generated over 240 hours of programming and over 200 artists across the LiveXLive music platform; over 49 million livestream views during the first half of FY20 versus 51 million during the entire FY19; extended payments of approximately $8.9M of payables owed to certain music content licensors over a weighted average period of approximately 21 months starting in October; an additional $0.4M was converted into LiveXLive shares of common stock at $4.51 per share; raised $9.5M in net cash proceeds from the sale of 5.0 million shares of common stock in July 2019; expect to close Q2 with cash and cash equivalents in excess of amount reported for Q1.

07:06 EDT IGM Biosciences initiates first-in-human Phase 1 clinical trial of IGM-2323 - IGM Biosciences announced that the first patient has been dosed in its Phase 1 clinical trial evaluating IGM-2323, the Company's CD20 x CD3 bispecific IgM antibody, in patients with relapsed/refractory B cell Non-Hodgkin's lymphoma. This Phase 1 clinical trial represents the first in-human application of IGM Biosciences' engineered IgM antibody technology. The Phase 1 multi-center, open label trial is intended to assess the safety, pharmacokinetics and preliminary efficacy of intravenous IGM-2323 in patients with relapsed/refractory B cell NHL. IGM-2323 will initially be administered at a planned fixed-dose, as part of a dose escalation protocol.

07:05 EDT Canopy Rivers invests additional $10M in TerrAscend - Canopy Rivers has completed a $10M investment in TerrAscend Canada, a subsidiary of its portfolio company TerrAscend Corp. The investment includes the purchase of 13,243 units, with each unit consisting of: (i) one unsecured convertible debenture of TerrAscend Canada with a principal amount of C$1,000, and (ii) 25.2 common share purchase warrants of TerrAscend exercisable until October 2, 2024.

07:04 EDT RA Pharmaceuticals doses first patient in zilucoplan Phase 3 clinical trial - Ra Pharmaceuticals announced the initiation of dosing in the RAISE study, its global, pivotal, Phase 3 clinical trial evaluating zilucoplan for the treatment of generalized myasthenia gravis, or gMG. The single, pivotal, randomized, double-blind, placebo-controlled Phase 3 trial is designed to evaluate the efficacy of a once-daily, subcutaneously self-administered dose of 0.3 mg/kg of zilucoplan versus placebo. The trial is expected to enroll approximately 130 patients with gMG who are acetylcholine receptor-antibody-positive, regardless of their prior therapies. The primary endpoint is the change in the MG Activities of Daily Living score from baseline to week 12. Following completion of the Phase 3 clinical trial, patients will have the option to enroll in the RAISE-XT study, an open-label, long-term extension study. Top-line results from this Phase 3 trial are expected in early 2021.

07:03 EDT Bruker acquires Magnettech's EPR business - Bruker acquired the Magnettech EPR business from Freiberg Instruments GmbH, and established a related, long-term EPR supply partnership with Freiberg Instruments. Financial details of the transaction were not disclosed. Magnettech's benchtop electron paramagnetic resonance system, the MiniScope MS 5000, and a range of Magnettech EPR accessories, expand Bruker's existing EPR portfolio. Freiberg Instruments, which has developed and is manufacturing the MiniScope MS 5000 EPR products, and Bruker have also agreed to a long-term EPR supply partnership, and Bruker intends to continue to work with some of Magnettech's key channel partners.

07:03 EDT Simon Property enters agreement with RGG for digital value shopping venture - Simon Property announced an agreement with Rue Gilt Groupe, or RGG, a company backed by entrepreneur Michael Rubin, to create a new multi-platform venture dedicated to digital value shopping. The new venture will combine Simon's in-store retail leadership with RGG's e-commerce knowledge and include RGG's Rue La La and Gilt platforms as well as Shop Premium Outlets, or SPO, Simon's new online outlet marketplace. Simon will contribute approximately $280M to the new venture including the value of SPO, which has been successfully beta tested since March. SPO will deliver brands at outlet pricing. For brands and retailers on the site, SPO will help drive additional online sales and support inventory optimization and customer acquisition. SPO currently encompasses over 2,000 designers and 300,000 products with many more merchants to join over time as enhancements are introduced to the site. Over the coming year, Simon will promote the new venture utilizing a portion of its over $100M plus annual marketing budget and access to two billion annual shopper visits. The partnership will also leverage the combined databases of Simon and RGG reaching over 35M shoppers. The closing of the transaction is subject to customary conditions, including certain regulatory approvals.

07:02 EDT Rockwell Automation, Schlumberger announce closing of Sensia JV - Rockwell Automation (ROK) and Schlumberger (SLB) announced the closing of their previously-announced joint venture, Sensia, the oil and gas industry's first digitally enabled, integrated automation solutions provider. "Sensia will make industrial-scale digitalization and seamless automation available to every oil and gas company so their assets can operate more productively and profitably," said Allan Rentcome, CEO of Sensia. "It will make oil and gas production, transportation and processing simpler, safer, and more secure." Headquartered in Houston, Texas, Sensia is projected to generate initial annual revenue of $400 million and employ approximately 1,000 employees. Sensia will operate as an independent entity, with Rockwell Automation owning 53% and Schlumberger owning 47% of the joint venture. Rockwell Automation made a $250 million cash payment to Schlumberger at closing.

06:48 EDT Merck's Keytruda approved as monotherapy in China for NSCLC - Merck's Keytruda anti-PD-1 therapy has been approved by the National Medical Products Administration in China as monotherapy for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer, or NSCLC, whose tumors express PD-L1 - tumor proportion score greater than or equal to 1%. This new indication was granted full approval based on the overall survival findings from the Phase 3 Keynote-042 trial. Keytruda is now the first anti-PD-1 therapy approved in China as both monotherapy and in combination with chemotherapy for the first-line treatment of appropriate patients with NSCLC. In the extension of the global study in Chinese patients, Keytruda monotherapy demonstrated a statistically significant improvement in OS compared with chemotherapy. Results from the Keynote-042 China extension study were recently presented for the first time at the IASLC 2019 World Conference on Lung Cancer.

06:44 EDT InfuSystem promotes Carrie Lachance to COO - InfuSystem Holdings has promoted Carrie Lachance to COO, effective October 1.

06:34 EDT Veru completes enrollment of Phase 2 trial in men with prostate cancer - Veru has achieved full enrollment for its Phase 2 clinical study of zuclomiphene citrate, a nonsteroidal oral estrogen receptor agonist for the treatment of androgen deprivation hormone therapy induced hot flashes in men who have advanced prostate cancer. The Phase 2 clinical study is a double-blind randomized placebo-controlled dose finding study evaluating two doses of oral daily zuclomiphene treatment versus placebo in approximately 95 men with advanced prostate cancer who have ADT induced moderate to severe hot flashes. The clinical study has a treatment duration of 12 weeks and is being conducted in 24 clinical centers in the U.S. The primary endpoint is the frequency of moderate to severe hot flashes. Secondary endpoints include severity of hot flashes and improvement in bone markers. The company expects topline efficacy results and safety data from this Phase 2 trial in the fall of 2019 and remains on track for initiation of the Phase 3 clinical study in early 2020. US peak sales for zuclomiphene citrate are estimated to be approximately $600M per year.

06:32 EDT Aptiv to acquire gabocom for about $310M - Aptiv announced that it has entered into a definitive agreement to acquire gabo Systemtechnik GmbH from funds managed by Bregal Unternehmerkapital for approximately $310M. The transaction is subject to regulatory approval and other customary closing conditions and is expected to close by the end of 2019. Upon completion of the transaction, gabocom will become a part of HellermannTyton, a business unit of Aptiv's Signal and Power Solutions segment. The transaction is expected to be modestly accretive to EPS in 2020.

06:29 EDT ReneSola regains compliance with NYSE - ReneSola announced that it regained compliance with the minimum average closing price criteria required by the New York Stock Exchange, or NYSE, for continued listing of the company's American Depositary Shares, or ADSs. On September 9, the company received notice from the NYSE that it did not meet the NYSE's price criteria for continued listing standard because the average closing price of the company's ADSs was less than $1.00 per ADS over a consecutive 30-trading-day period. Under NYSE rules, the company has six months following receipt of the notification to regain compliance with the minimum share price requirement. The company can regain compliance at any time during the six-month cure period if the company's ADSs have a closing share price of at least $1.00 on the last trading day of any calendar month during the period and also has an average closing share price of at least $1.00 over the 30 trading-day period ending on the last trading day of that month or on the last day of the cure period. On October 1, the company received confirmation from the NYSE that it had regained compliance with continued listing standards after the average closing price for its ADSs for the consecutive 30-trading-day period ended September 30 exceeded $1.00.

06:13 EDT Arthur J. Gallagher acquires Anthony Hodges Consulting, terms undisclosed - Arthur J. Gallagher announced the acquisition of Wakefield, England-based Anthony Hodges Consulting, or AHC. Terms of the transaction were not disclosed. Founded in 1996, AHC is a pension, change and reward benefit communications consultancy serving clients across the United Kingdom, United States and Australia with offices in Minneapolis and Melbourne. Roger Hattam and his associates will continue to operate from their current locations under the direction of Nick Burns, head of Gallagher's U.K. employee benefits consulting and brokerage operations.

06:03 EDT Axonics to supply sacral neuromodulation systems to urology practice group - Axonics has entered into an exclusive agreement to supply the Axonics r-SNM System to Adult Pediatric Urology and Urogynecology, headquartered in Omaha, Nebraska. ADPU's physicians have been successfully implanting SNM devices for more than a decade, purchasing approximately $2.5M annually. ADPU is the first large group practice in the U.S: that has agreed to make Axonics the sole supplier of r-SNM Systems for its patients.

05:57 EDT General Electric to pay $2.72M over Cuba sanctions, Treasury Dept. says - General Electric, on behalf of three current and former GE subsidiaries, Getsco Technical Services Inc., Bentley Nevada, and GE Betz, has agreed to pay $2.72M to settle its potential civil liability for 289 alleged violations of the Cuban Assets Control Regulations. Specifically, between December 2010 and February 2014, the GE Companies appear to have violated Section 515.201(b) of the CACR on 289 occasions by accepting payment from The Cobalt Refinery Company for goods and services provided to a Canadian customer of GE. In total, the GE Companies received 289 checks directly from Cobalt from on or about December 9, 2010 to on or about February 28, 2014 totaling approximately $8.01M. Additionally, goods and services the GE Companies provided to its Canadian customer were, in turn, used to supply utility services and other benefits to Cobalt, which is co-located with GE's Canadian customer. The Treasury Department said in a statement, "While OFAC considered certain jurisdictional limitations on GE's ability to provide a full picture of the scope of work performed at the request of its Canadian customer, at all relevant times, GE had reason to know of its customer's specific and longstanding relationship with Cobalt. GE should have treated its Canadian customer as higher risk due to the customer's publicly known joint venture with Cuba and substantial reliance on Cuban-origin ore. Finally, despite the provision to GE of OFAC's Office of Enforcement Data Delivery Standards, GE did not provide its primary submissions to OFAC in a clear and organized manner and the submissions contained numerous inaccuracies, placing a substantial resource burden on OFAC during the course of its investigation." Reference Link

05:35 EDT The Stars Group to be acquired in all-share combination by Flutter Entertainment - The boards of Flutter Entertainment and The Stars Group announce that they have reached agreement on the terms of a recommended all-share combination to be implemented through an acquisition of TSG by Flutter pursuant to a plan of arrangement under the Business Corporations Act. The Combination will bring together two complementary businesses to create a global leader in sports betting and gaming. The Combined Group will have a diverse portfolio of leading brands and complementary best-in-class products with a broad geographic reach. Flutter and TSG would each bring to the Combined Group a proven track record in using product and brand leadership to create low-cost customer acquisition channels, while optimising value through product cross-sell. It will benefit from an enhanced global platform and improved local market reach. On a proforma basis, the Combined Group's annual revenue would have been GBP 3.8bn in 2018, making it the largest online betting and gaming operator globally. The Combined Group will be incorporated, headquartered and domiciled in Dublin, Ireland with a premium listing on the London Stock Exchange and a secondary listing on Euronext Dublin. The combination is anticipated to deliver substantial value creation for shareholders from pre-tax cost synergies of GBP 140M per annum, along with potential revenue cross-sell in international markets and lower finance costs.

05:06 EDT Ballard Power receives purchase order for 3 FCveloCity 100 kW fuel cell modules - Ballard Power announced receipt of a purchase order for 3 of its FCveloCity 100 kilowatt, or kW, fuel cell modules from Berlin-based BEHALA, a port and logistics specialist, to power the world's first zero-emission push boat. The boat, to be named Elektra, will be used primarily to transport goods between Berlin and Hamburg as well as on inner-city transport routes in Berlin. Ballard plans to work with BEHALA and other consortium partners to assist in the design, construction and deployment of the Elektra, with construction of the almost 20 meter long and 8.2 meter wide push boat scheduled to begin this month at the Hermann Barthel shipyard in Derben, Germany, and completion expected by end-2020.