Stockwinners Market Radar for July 23, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:44 EDT Intra-Cellular updates on lumateperone info provided to FDA - Intra-Cellular Therapies announced that the FDA has confirmed the Psychopharmacologic Drugs Advisory Committee meeting scheduled for July 31, 2019 to discuss the New Drug Application for lumateperone for the treatment of schizophrenia. The company recently provided additional information to the FDA in response to information requests relating to non-clinical studies. The FDA cancelled the Advisory Committee meeting to allow sufficient time to review this new and any forthcoming information as they continue the NDA review. This information may result in an extension of the September 27, 2019 Prescription Drug User Fee Act PDUFA target action date for the lumateperone NDA. The company has a meeting scheduled with the FDA shortly and will provide an update following the meeting.

18:56 EDT Fly Intel: After Hours Movers - UP AFTER EARNINGS: Jounce (JNCE) up 35.7%... Teradyne (TER) up 17.5%... Edwards Lifesciences (EW) up 10.3%... Manhattan Associates (MANH) up 10.0%... Snap (SNAP) up 9.2%... Texas Instruments (TXN) up 6.4%... Old Line Bancshares (OLBK) up 5.2%... Carlisle (CSL) up 4.2%... Chipotle (CMG) up 3.3%... Canadian National (CNI) up 2.7%... Discover (DFS) up 2.3%... Navient (NAVI) up 1.8%. ALSO HIGHER: Wells Fargo (WFC) up 0.4% after raising dividend and boosting buyback. DOWN AFTER EARNINGS: iRobot (IRBT) down 17.0%... Robert Half (RHI) down 0.5%... Visa (V) down 0.3%. ALSO LOWER: Seatte Genetics (SGEN) down 3.8% after equity offering... Facebook (FB) down 1.7%, Twitter (TWTR) down 1.0%, Amazon (AMZN) down 1.2%, Alphabet (GOOG) down 1.0% after DoJ announced probe into competition stifling efforts by large tech firms. Movers as of 18:30ET.

18:32 EDT Regulus announces a program update for RGLS4326 - Regulus Therapeutics announced a program update for RGLS4326 for the treatment of Autosomal Dominant Polycystic Kidney Disease, or ADPKD. The Company has been working with the FDA since July 2018, when Regulus voluntarily paused the Phase 1 clinical program due to unexpected findings in the mouse chronic toxicity study being run in parallel with the Phase 1 program. In consultation with FDA, Regulus provided the interim analyses from a new mouse chronic toxicity study and the non-human primate, or NHP, chronic toxicity study and supporting information to enable re-initiation of the Multiple Ascending Dose, or MAD, study. After review of the requested submission, FDA notified the Company of additional nonclinical data requirements and placed the IND on a partial clinical hold, formalizing the specific requirements to reinitiate the MAD study and further proceed into chronic dosing in ADPKD patients.

18:09 EDT Valmont reports Q2 operating margin 9.1% vs. 10.4% last year - CEO Stephen G. Kaniewski says: "We had a good quarter across the majority of our businesses, despite substantial, unfavorable comparisons in the Irrigation segment, and we exceeded last year's performance after excluding non-recurring expenses. Sales growth was led by robust transportation and wireless communication demand, particularly in North America markets, revenue from acquisitions, and favorable pricing across the portfolio. We experienced favorable demand in three of our four segments. Strong order flow in Engineered Support Structures accelerated during the quarter, increasing backlogs and significantly extending lead times, demonstrating market strength. Utilities Support Structures saw continued investments in grid hardening and modernization, while Coatings benefited from general economic growth and revenue from recent acquisitions. Lower sales in Irrigation, coupled with lower profitability in the international portion of our Utility business, led to overall results that were below our expectations. We were pleased to have generated strong, second quarter operating cash flows of $105 million, due to our lean efforts and receipt of a project downpayment."

18:01 EDT Alvic agrees on terms of investment from KKR, Arta Capital - Alvic Group reached an agreement on the terms of an investment from KKR and Arta Capital, a Spanish midmarket private equity firm sponsored by the financial and investment group Grupo March. Alvic is a Spanish panel and componentry manufacturer for kitchen and office furniture with more than 70% of its revenues coming from outside Spain. The current team led by Javier Rosales will continue managing the company.

17:50 EDT SPDR Gold Shares holdings fall to 823.13MT from 825.18MT - This is the first decline in holdings since July 16th.

17:48 EDT Visa says Libra in 'early days' - Says can be helpful in Facebook Libra association.

17:44 EDT FAANG names drop after DOJ says probing market-leading online platforms - Shares of Facebook (FB) and Google (GOOG) are down approximately 1.5%, Netflix (NFLX) and Apple (AAPL) are down fractionally, while Amazon (AMZN) is lower by approximately 2%. Microsoft (MSFT) and Oracle (ORCL) are also fractionally lower in the after-market on Tuesday evening.

17:22 EDT Visa says Q3 'an exciting quarter' for the company - Says Q3 'an exciting quarter' for the company. Says aims to expand network with acceptance options and payment options. Says fuel prices ultimately a growth driver in Q3. Says growth in EMEA remained "robust" in Q3. Says Latin America growth driven by improvement in Brazil and Mexico.

17:16 EDT J.M. Smucker raises dividend 4% to 88c - The J. M. Smucker announced that the Board of Directors has approved an increase in the quarterly dividend from 85c to 88c per common share, an increase of 4%. The dividend will be paid on Tuesday, September 3 to shareholders of record at the close of business on Friday, August 16. This represents the Company's eighteenth consecutive year of dividend growth.

17:01 EDT Northern Trust rises dividend 17% to 70c - Northern Trust, holding company of The Northern Trust Company, has declared a quarterly cash dividend of 70c per share on its common stock, payable on October 1. The dividend represents an increase of approximately 17% from the prior quarterly rate of 60c per share, and results in an annualized dividend rate of $2.80, compared with the prior annualized rate of $2.40. Northern Trust Corporation also declared cash dividends of $365.625 per share of its Series C non-cumulative perpetual preferred stock, and $2,300.00 per share of its Series D cumulative perpetual preferred stock, each payable on October 1.

16:55 EDT Canadian National sees mid single-digit RTM growth in 2019 - Canadian National sees mid single-digit RTM growth in 2019, pricing above rail inflation. Comments taken from investor slides presentation.

16:51 EDT iHeartMedia disposes entire stake in Clear Channel Outdoor

16:45 EDT Wells Fargo board approves buyback authorization increase of 350M shares - The Wells Fargo board of directors also increased the company's authority to repurchase common stock by an additional 350M shares. Wells Fargo has approximately 4.4B shares outstanding.

16:43 EDT Wells Fargo raises quarterly dividend to 51c from 45c per share - The dividend is payable Sept. 1, 2019 to stockholders of record on Aug. 9, 2019 and is part of the company's 2019 Capital Plan, which was submitted to the Federal Reserve as part of the recently concluded Comprehensive Capital Analysis and Review, or CCAR.

16:39 EDT United Rentals' Roof acquires 5,000 common shares - In a regulatory filing, United Rentals director Donald C. Roof disclosed the purchase of 5,000 common shares of the company at a price of $118.2724 per share.

16:32 EDT TechnipFMC awarded EPC contract in Arctic LNG2 project by Novatek - TechnipFMC has been awarded a major Engineering, Procurement and Construction, or EPC, contract by Novatek and its partners for the Arctic LNG 2 project located in the Gydan peninsula in West Siberia, Russia. This development will consist of three liquefied natural gas, or LNG, trains, each with a capacity of 6.6 Mtpa which will be installed on three gravity-based structure platforms. TechnipFMC will execute this project under a lump sum and reimbursable basis. It will cover the EPC of the three LNG trains and associated topsides, which will be manufactured on a modular basis in Asian and Russian yards.

16:27 EDT Berkshire Hills Bancorp declares quarterly cash dividend of 23c per share - To shareholders of record at the close of business on August 8, payable on August 22.

16:24 EDT iRobot down 16% to $74.87 after lowering FY19 guidance

16:22 EDT State Street files 2019 resolution plan - State Street Corporation announced that it has filed its 2019 resolution plan. State Street, along with other banking institutions with $50B or more in total assets, periodically prepares and files its resolution plan, commonly referred to as a "living will," with the Board of Governors of the Federal Reserve System and the Federal Deposit Insurance Corporation. The resolution plan details State Street's efforts to enhance resolvability across its business in line with applicable rules and guidance.

16:21 EDT Ligand to acquire Ab Initio for $12M - Ligand Pharmaceuticals announces the signing of an agreement with Ab Initio Biotherapeutics whereby Ligand will acquire Ab Initio for $12M in cash. Ab Initio was a privately held antigen-discovery company based in South San Francisco, California. Antigen design and preparation are the first steps necessary for the discovery of therapeutic antibodies. This transaction will have minimal impact on Ligand's future cost structure.

16:17 EDT Transcat sees continued Services revenue strength - CEO Lee Rudow says: "All signs point to continued strength on the Service revenue front as our pipelines for new business and acquisitions remain robust. We still expect our operational excellence initiatives to benefit gross and operating margins during this fiscal year, and certainly more so over the long term. While we saw strong Distribution sales growth in the first quarter, a good portion was from the alternative energy sector and sales of used equipment, both of which can vary quarter-to-quarter."

16:16 EDT Mercury Systems receives $12M follow-on order - Mercury Systems announced it received a $12M follow-on order from a leading defense prime contractor for high-performance digital signal processing subsystems for an unmanned airborne intelligence, surveillance and reconnaissance application. The order was booked in Q4 and is expected to be shipped over the next several quarters.

16:14 EDT Snap CEO says looks forward to building on momentum - "The growth in our community, engagement, and revenue is the result of several transitions we completed over the past 18 months. We look forward to building on our momentum and making significant ongoing progress in each of these areas," said CEO Evan Spiegel. The company added: "We are seeing early results from the improvements of our Android application. On the majority of Android devices used by new users, Snapchatters are now sending 7% more Snaps when compared to the old version, which we believe is an important leading indicator of their long-term retention. We saw more than a 10% increase in the retention rate of people who open Snapchat for the first time."

16:13 EDT Chipotle says opened 20 new restaurants and closed 1 in Q2

16:13 EDT UPS launches pick-up and returns in over 6,000 CVS locations - UPS (UPS) announced the addition of UPS Access Point locations in standalone CVS (CVS) Pharmacy locations nationwide, allowing consumers to pick up and return packages. The collaboration is set to begin rolling out immediately and is planned for more than 6,000 stores.

16:12 EDT Snap reports Q2 Daily Active Users increased 8% year-over-year to 203M - Snap said it added 13M Daily Active Users in the second quarter and saw increased engagement across key metrics. DAUs were 203M in Q2 2019, compared to 190M in Q1 2019 and 188M in Q2 2018. DAUs were up sequentially and year-over-year in each of North America, Europe, and Rest of World. DAUs were up sequentially and year-over-year on each of iOS and Android platforms. The average number of Snaps created every day grew to more than 3.5B in Q2 2019.

16:11 EDT Visa edges higher after Q3 earnings beat

16:10 EDT Frontdoor creates Denver Technology Campus - Frontdoor announced it is creating a technology campus in Denver, bringing additional capacity to the company's technology and engineering teams based in Memphis, Phoenix and other locations. The Denver site will help the company accelerate the pace of innovation as it builds products, platforms and service enhancements to transform its operations and the $400B home services industry. When complete, the new campus will be located in the heart of downtown, near Union Station, and will include professionals in engineering, UX and interactive design, UX research, project management, data science, service desk support and more. In recent weeks, the company has filled nearly 20 of the up to 100 positions that are currently planned for the center. These individuals are working in a temporary space downtown while the company renovates existing office space to create a vibrant, open and collaborative feel that matches its startup energy and culture. The new space will be ready to be occupied later this year.

16:10 EDT Old Line Bancshares trading halted, news pending

16:09 EDT Texas Instruments up 6% to $127.40 after Q2 results beat estimates

16:07 EDT StarTek names Rajiv Ahuja as COO - Startek appointed Rajiv Ahuja as the company's new global chief operating officer. Effective immediately, Ahuja will assume responsibility for global operations and customer success at Startek as both Pete Martino, COO of the Americas and Philippines, and Sandeep Gulati, COO of APAC and South Africa, will be leaving the company to pursue other interests. Ahuja previously served as the SVP & country manager for India, China, Malaysia and Japan at Convergys.

16:06 EDT Newmont Goldcorp to succeed Gary Goldberg as CEO on October 1st - Newmont Goldcorp announced that, effective October 1, Tom Palmer, President, will succeed Gary Goldberg to become the company's President and CEO and join the board. As previously announced in January, Mr. Goldberg will retire from Newmont Goldcorp after more than seven years of service. From October 1, 2019 through March 31, 2020, Mr. Goldberg will serve as Executive Advisor to support Mr. Palmer and the Executive Leadership Team.

16:04 EDT Texas Instruments CEO says 'broad based weakness' in Q2 - Rich Templeton, TI's chairman, president and CEO, made the following comments: "Revenue decreased 9% from the same quarter a year ago due to broad-based weakness. In our core businesses, Analog revenue declined 6% and Embedded Processing declined 16% from the same quarter a year ago. Our cash flow from operations of $7.2 billion for the trailing 12 months again underscored the strength of our business model. Free cash flow for the trailing 12 months was $5.9 billion and 39% of revenue. This reflects the quality of our product portfolio, as well as the efficiency of our manufacturing strategy, including the benefit of 300-millimeter Analog production. We have returned $8.0 billion to owners in the past 12 months through stock repurchases and dividends. Our strategy is to return all our free cash flow to owners. Over the last 12 months, our dividends represented 47% of free cash flow, underscoring their sustainability."

16:03 EDT Jounce announces update on strategic collaboration with Celgene - Jounce Therapeutics (JNCE) announced an update on its strategic collaboration with Celgene Corporation (CELG), originally established in July 2016. Under the terms of a new license agreement, Celgene has licensed worldwide rights to JTX-8064, a highly-selective, potential first-in-class antibody that targets the LILRB2 receptor on macrophages. Jounce retains full worldwide rights to its pipeline beyond JTX-8064, including vopratelimab, JTX-4014 and all discovery programs, as Jounce and Celgene have also entered into a mutual agreement to terminate their original strategic collaboration agreement.Under the terms of the new license agreement for JTX-8064, Jounce receives a $50.0 million non-refundable license fee and is eligible to receive from Celgene up to $480 million in development, regulatory and commercial milestone payments, as well as royalties on potential worldwide sales. Celgene will be responsible for all development and commercialization of JTX-8064. "We are grateful for Celgene's investment and support of Jounce over the past three years as it has helped us grow our diversified pipeline and further enhance our translational science platform. We are proud of the many accomplishments we have achieved under the original agreement with Celgene and remain committed to developing innovative immunotherapies for patients with cancer," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "The discovery and development of JTX-8064 showcases the strength of our translational science platform, validating our approach to discovering novel immunotherapies for patients in need. We look forward to the advancement of JTX-8064 by Celgene. Most importantly, we retain full global rights to all of our other programs, including vopratelimab, giving Jounce greater flexibility to create value for patients and shareholders moving forward. In addition to our ongoing clinical development programs, we are also poised to expand our broader pipeline and advance additional novel immunotherapy programs based on our translational science platform."

15:57 EDT American Midstream Partners trading resumes

15:13 EDT Ally Financial officer Diane Morais sells over $500K in company shares - Ally Financial officer Diane Morais disclosed in a regulatory filing that she had sold 15,000 shares of company stock at $33.35 per share on July 23. The total transaction value of the sale was $500,250.

14:29 EDT Intra-Cellular drops, halted after FDA advisory committee meeting cancelled - Shares of Intra-Cellular Therapies (ITCI) dropped sharply and the stock was halted for volatility after the FDA cancelled an advisory committee meeting that had been planned to discuss an application made by the company. In a post on its website, the FDA stated: "The meeting of the Psychopharmacologic Drugs Advisory Committee meeting for July 31, 2019 is cancelled. This meeting has been cancelled because of new information regarding the application. The Agency intends to continue evaluating the application and, as needed, will announce future meeting dates in the Federal Register." The committee meeting had been planned to discuss new drug application 209500, lumateperone tosylate capsules for oral administration, submitted by Intra-Cellular Therapies, for the treatment of schizophrenia. Prior to being halted, Intra-Cellular shares fell $1.76, or 14.7%, to $10.22. Reference Link

14:26 EDT NTSB chairman says FRA did not act on signal suspension recs in Feb. 4 collision - Robert Sumwalt, chairman of the NTSB, said the following in his closing statement on a fatal collision of an Amtrak and a CSX train on February 4, 2018: "We reiterated more recommendations than we issued today. That should not happen. That said, today's new, reiterated, and reclassified recommendations, if acted upon, will make railroad transportation safer for passengers and train crews. Those recommendations that are urgent address imminent threats to life and safety on our railroads. Unfortunately, in the wake of this tragic collision in Cayce, FRA did not act on our urgent recommendation regarding signal suspension. We had no choice but to close it in an unacceptable classification. Our recommendations will require action by several parties, including the regulator. It is time for railroads to eliminate the possibility of employees failing to perform critical tasks such as lining a switch, lining a derail, or ensuring cars are in the clear. It is past time for the FRA to act on Part 270, System Safety Program. But if the regulator will not act, as I mentioned earlier, individual railroads should develop their own SSPPs, as we have recommended that CSX do, and as Amtrak has done. I don't think the tragic irony of this collision is lost on anybody. Positive Train Control is designed to prevent accidents involving switches being left in the wrong position. This accident happened when the rail signals were being upgraded to accommodate PTC. In the end, PTC will save lives and prevent accidents like this. But whenever railroads temporarily take protections off-line, they must assess and mitigate risk. Unfortunately, that did not happen here."

14:07 EDT Continental AG jumps despite lower guidance, peers spike after punishing year - Shares of auto parts makers are trading higher after tire maker Continental Aktiengesellschaft (CTTAY) reported quarterly results Monday night. CONTINENTAL MEETS EXPECTATIONS: Continental, which lowered its FY19 outlook, said: "Though the decline in the automotive industry also affected Continental's business in the second quarter of 2019, preliminary key data indicate that the period's results meet current analyst expectations." LOWERS OUTLOOK: "Whereas the previously communicated outlook was based on expectations of a flat development in global light vehicle production in fiscal 2019 versus the previous year, current expectations are for a decline of around 5%. This will result in consolidated sales and an adjusted EBIT margin below the previously communicated outlook ranges. These figures will also be below current analyst expectations. Unanticipated changes in customer demand are causing volume declines for certain products in the Automotive Group," Continental said. HAS GROUP BOTTOMED?: Shares of Continental AG are down 93% since 2013. Shares peaked at $219.50 in late 2013, and hit a low of $12.83 in 2019. This time last year, Visteon (VC) was trading at $140.64 per share, compared to its recent low of about $44 per share, a 69% drop. Other U.S based auto parts makers, including American Axle & Manufacturing (AXL) and Lear Corporation (LEA), have seen large price declines over the past 12 months. PRICE ACTION: Shares of Continental Ag are up 7%, Visteon and American Axle are both up around 5%, while Lear is up approximately 2%.

13:36 EDT Curaleaf Holdings says it 'will work collaboratively' with FDA to resolve issues - Curaleaf Holding issued the following statement in response to a letter from the U.S. Food and Drug Administration regarding its CBD product marketing: "Curaleaf is committed to the highest standards of quality and compliance, and will work collaboratively with the FDA to resolve all issues addressed in the agency's letter. The Company will respond to the FDA letter within the required 15 working days. Compliance is a top priority for Curaleaf and the Company is fully committed to complying with FDA requirements for all of the products that it markets. We can affirm that nothing in the letter raises any issues concerning the quality and consistency of any Curaleaf product or calls into question the high safety standards of the Company's cultivation and manufacturing processes. Curaleaf CBD products are all derived from hemp and meet the requirements of the Farm Bill."

13:16 EDT Sodexo takes minority stake in Indian fintech company Zeta - Sodexo announced that its Benefits & Rewards Services activity has entered into final discussions to take a strategic minority stake in Zeta, which has been partnering with Sodexo BRS India since 2017. This investment will be part of BRS's on-going strategic initiatives to reinforce its technology and development capacities to accelerate digitization in all its activities around the world, the company said in a statement. "Our investment in Zeta will give us the opportunity to accelerate our digitization journey globally. This investment will bring together the agility and technical skills of Zeta and Sodexo's expertise in Employee Benefits Services to enhance the overall Employee Experience," said Aurelien Sonet, CEO, Sodexo Benefits & Rewards Services.

13:03 EDT Kura Oncology granted orphan status for leukemia treatment - The FDA granted Kura Oncology orphan status for its treatment of acute myeloid leukemia. Reference Link

12:38 EDT Nike adds Zion Williamson to Jordan Brand family - Nike said in an announcement on its website, "Zion Williamson, who grew up in Florence, South Carolina, was selected first overall in the 2019 NBA Draft. Joining a family of 50-plus athletes across multiple sports, the incoming professional is the latest member of Jordan Brand's hardwood roster." Reference Link

12:33 EDT Healthcare Trust raises quarterly dividend 1.61% to 31.5c per share - Healthcare Trust of America announced that its board of directors has increased the quarterly dividend by 1.61% to 31.5c per share of common stock. This represents an annualized rate of $1.26 per share of common stock with an annualized yield of 4.64% based on HTA's closing share price as of July 22, 2019. The dividend will be paid on October 10, 2019 to stockholders of record on October 3, 2019. Additionally, the eligible holders of HTA's operating partnership units will receive a quarterly OP Unit distribution, which is on par with HTA's common stock dividend described above.

12:31 EDT Eagle Bancorp jumps after quarterly report, dividend raise, repurchase pact - Earlier on Tuesday, Eagle Bancorp Montana reported net income of $3.2 million, or $0.51 per diluted share, in the second quarter of 2019, compared to $1.2M or 18c per diluted share, in the first quarter of 2019, and $1.3M, or 24c per diluted share, in the second quarter of 2018. There were $5,000 in acquisition-related expenses in the second quarter of 2019, compared to $1.2M in the preceding quarter and $131,000 in the second quarter a year ago. In the first six months of 2019, net income increased 132.4% to $4.4 million, or 69c per diluted share, compared to $1.9M, or 35c per diluted share, in the first six months of 2018. Additionally, Eagle's board of directors increased its regular quarterly cash dividend by 2.7% to 9.5c per share on July 18. The dividend will be payable September 6, 2019 to shareholders of record August 16. The current annualized yield is 2.29% based on recent market prices. "Eagle's record second quarter operating results were highlighted by double-digit loan and deposit growth year-over-year and solid net interest income," stated Peter J. Johnson, President and CEO. "All of our operating metrics improved during the quarter as we surpassed the $1 billion asset milestone. At the same time, the successful integration of our two recent acquisitions is providing us with additional opportunities for improvement. We will continue to look for growth opportunities in and around our surrounding markets that benefit both our customers and shareholders." Additionally, Eagle announced that its Board of Directors has authorized the repurchase of up to 100,000 shares of its common stock, representing approximately 1.56% of outstanding shares. Under the plan, shares may be purchased by the company on the open market or in privately negotiated transactions. The extent to which the company repurchases its shares and the timing of such repurchase will depend upon market conditions and other corporate considerations. Shares of Eagle Bancorp are up 67c or 4.3% to $16.35 per share in early afternoon trading.

12:20 EDT NTSB blames CSX safety lapses for fatal collision in 2018 - The conclusions are being announced by The National Transportation Safety Board during its ongoing public meeting regarding the probable cause of the Feb. 4, 2018, collision of an Amtrak and a CSX train near Cayce, South Carolina. Reference Link

12:00 EDT Innovative Industrial Properties falls -10.2% - Innovative Industrial Properties is down -10.2%, or -$11.59 to $101.56.

12:00 EDT Lannett falls -15.7% - Lannett is down -15.7%, or -$1.32 to $7.10.

12:00 EDT Realogy rises 15.2% - Realogy is up 15.2%, or 79c to $5.96.

11:47 EDT Lockheed Martin sees spending $1.7B on CapEx annually for next few years

11:25 EDT Lockheed Martin CFO: F-35 program tracking ahead of YTD plan

11:22 EDT Lockheed Martin says sees increasing global demand for F-35

11:07 EDT Gilead presents additional results from DISCOVER trial of Descovy for PrEP - Gilead Sciences announced that it presented additional results from the DISCOVER trial evaluating an investigational use of Descovy for HIV pre-exposure prophylaxis, or PrEP. In a sub-analysis of the DISCOVER trial, Descovy reached intracellular drug concentration levels above the estimated protective threshold significantly more quickly than Truvada, and additional pharmacokinetic data confirm that these drug concentration levels persist longer than Truvada, the company stated. The results were presented at the 10th International AIDS Society Conference on HIV Science.

11:06 EDT Merck announces results from Phase 1 study evaluating islatravir - Merck announced results from a Phase 1 study evaluating the pharmacokinetics and safety of a prototype subdermal drug-eluting implant for extended administration of islatravir, the company's investigational nucleoside reverse transcriptase translocation inhibitor, in healthy volunteers. The early findings of this prototype were presented as a late-breaking oral presentation at the 10th International AIDS Society Conference on HIV Science in Mexico City and featured in the official IAS 2019 press program. Merck is conducting a broad development program to evaluate the potential of islatravir for the treatment and prevention of HIV-1 infection. The lead program in treatment of HIV-1 infection is assessing a once-daily, oral, 2-drug regimen. The company is also exploring several potential options for PrEP, including a drug-eluting implant, as noted above, and a once-monthly oral formulation. The investigational once-daily, 2-drug regimen for the treatment of HIV-1 treatment will be presented as a late-breaking oral presentation tomorrow and is in the official press program at the IAS 2019. For the once-monthly oral formulation for PrEP, Merck plans to initiate a Phase 2, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of investigational oral islatravir once-monthly in participants at low- risk for HIV-1 infection. The trial is due to commence recruitment in September 2019. The Phase 1 randomized, 2-panel, double-blind, placebo-controlled, adaptive design clinical trial evaluated the safety and pharmacokinetics of islatravir administered using a polymer drug eluting implant, approximately the size of a match, in healthy adult volunteers. Participants were randomized to receive an implant containing islatravir at doses of either 62 mg, 54 mg or placebo that was inserted sub-dermally in the skin of the upper arm of the non-dominant hand. After 12 weeks the implant was removed, and participants were evaluated for a further 4 weeks. Both implant doses resulted in intracellular concentrations of islatravir, as measured in peripheral blood mononuclear cells, that remained above calculated pharmacokinetic thresholds through 12 weeks. Based on subsequent modeling, the implant containing islatravir 62mg was estimated to deliver levels well above the threshold at 12 months (and even beyond), providing early evidence for its potential as a once-yearly option for PrEP. The results of the study also indicate that control of intracellular concentrations can be managed by varying the islatravir load in the implant. In this study, there were no discontinuations due to adverse events and no severe implant-related AEs reported. All participants reported at least one AE and all drug-associated AEs were assessed to be mild or moderate in severity. The most common reported AEs occurred at the implant site and included hematoma, pain/tenderness, erythema, induration and pruritus for the 62mg; 54mg and placebo groups respectively. There were no clinically significant differences observed between islatravir and placebo groups in pooled analysis of vital signs, ECG parameters, and safety laboratory studies. No systemic drug associated effects were noted.

11:04 EDT Lockheed Martin CEO says believes F-35 program remains 'healthy' - Says on track to deliver 131 F-35s this year. Comments taken from Q2 earnings conference call.

11:02 EDT Ionis Pharmaceuticals slides after Biogen reports Q2 Spinraza sales - Shares of Ionis Pharmaceuticals (IONS) are lower in morning trading after partner Biogen (BIIB) reported Q2 Spinraza sales earlier this morning. In the second quarter of 2019, Spinraza revenues of $488M were comprised of $231M in sales in the U.S. and $258M in sales outside the U.S., Biogen reported before the open. The number of commercial patients receiving Spinraza grew approximately 4% in the U.S. and approximately 17% outside the U.S. versus the first quarter of 2019. Versus the first quarter of 2019, Spinraza revenues outside the U.S. decreased 13%, due primarily to a positive pricing adjustment in France in the first quarter of 2019, the timing of shipments across several international markets, and a continued transition from loading to maintenance doses in more mature markets, Biogen said. Near 11 am ET, Ionis shares are down 7% to $64.13.

10:23 EDT JetBlue sees FY20 CASM ex-fuel down 2.5%-0.5% - Management sees NEO delays into 2020 to lower capacity guide by approximately 2 percentage points. 2020 cost guidance is unchanged; however, lower capacity expected to add some pressure to unit costs.

10:20 EDT JetBlue looking to keep unit cost growth flat over next 10 years

10:17 EDT Kimberly-Clark says sees stronger free cash flow in 2H

10:11 EDT Crane says would considering paying more than $48/share if Circor would engage - Crane (CR) says on its Q2 earnings conference call that it would consider paying more than its last offer of $48 per share if Circor (CIR) would "engage and demonstrate that the company is worth more than that."

10:03 EDT Alector treatment of frontotemporal dementia granted FDA orphan status - Alector's treatment of frontotemporal dementia was granted FDA orphan status, according to a post to the agency's website. Reference Link

10:02 EDT Regeneron's pozelimab granted FDA orphan designation - Regeneron Pharmaceuticals' pozelimab was granted FDA orphan designation as a treatment of Paroxysmal Nocturnal Hemoglobinuria, according to a post to the agency's website. Reference Link

10:00 EDT Lannett falls -7.7% - Lannett is down -7.7%, or -65c to $7.77.

10:00 EDT Just Energy falls -14.4% - Just Energy is down -14.4%, or -63c to $3.75.

10:00 EDT AutoNation rises 10.8% - AutoNation is up 10.8%, or $4.51 to $46.46.

09:59 EDT Lakeland Industries appoints Allen Dillard as CFO - Lakeland Industries announced the appointment of Allen Dillard to the position of Chief Financial Officer, effective August 12. Dillard replaces Teri Hunt who resigned on May 10. For the past 4 years, Dillard has served as CFO of Digium, a technology-enabled provider of products and services to small and medium sized businesses. The company will be taking a one-time charge of approximately $260,000 in the fiscal quarter ending July 31 relating to the departure of Hunt, Lakeland noted. Christopher Ryan, President and CEO of Lakeland, said, "While we are encouraged by what our new CFO will bring to Lakeland, he comes at a time when we are making important progress in areas that he will be responsible for going forward. Specifically, I am pleased to report that the implementation of our enterprise resources planning solution is on track with the timing we had addressed with our most recent update when reporting fiscal first quarter results...The ERP system is starting to deliver its intended results. In the fiscal second quarter thus far, we are experiencing improvements in cost of goods sold due to our ability to track materials and expedite orders...So far, the system may have shortened our overall product manufacturing cycle by about 2 weeks. This will eventually equate to a reduction in certain stock levels by in excess of 20% or approximately $2.5M or more in the United States. We believe we are finally at the point where we are realizing improved efficiencies that will result in decreased inventory levels, increased free cash flow as inventories are run down and reduced customer lead-times...The ERP implementation has been a far lengthier process than we or our customers had anticipated, and it has taken its toll on our financial performance in past quarters and, perhaps, our share price. As we believe that our common shares are undervalued, Lakeland has commenced to repurchase its stock in accordance with the $2.5M stock repurchase program approved on July 19, 2016. While no stock was purchased in the fiscal first quarter ended April 30, 2019, the company has commenced the repurchase of shares in the fiscal second quarter. An update of the buyback program will be reported upon the filing of the company's fiscal second quarter financial results expected on September 9."

09:47 EDT Lannett falls -5.1% - Lannett is down -5.1%, or -43c to $7.99.

09:47 EDT Just Energy falls -11.4% - Just Energy is down -11.4%, or -50c to $3.88.

09:47 EDT New Oriental Education rises 6.4% - New Oriental Education is up 6.4%, or $6.25 to $104.54.

09:45 EDT Harley-Davidson CEO says profit margins to recover in FY20 with fixed EU tariffs - Harley-Davidson CEO Matt Levatich said the company expects U.S. retail sales improving in the second half of FY19. Comments taken from Q2 earnings conference call.

09:40 EDT Eaton appoints Silvio Napoli to board of directors - Eaton (ETN) announced that Silvio Napoli has been appointed to the company's Board of Directors effective July 26, 2019. Napoli is the executive chairman of the Board of Directors of Schindler Holding AG (SHLAF). Napoli succeeds Arthur E. Johnson, who will retire at the end of year after reaching the mandatory retirement age.

09:33 EDT United Technologies says 'very confident' about updated FY19 guidance - Says: More good things to come... Excited about the future... Will continue to invest in GTF engine technology.

09:31 EDT Harley-Davidson sees Q3 motorcycle shipments 43,000-48,000

09:28 EDT Marinus drops 66% to $1.35 after postpartum depression data

09:20 EDT Therapix Biosciences trading halted, news pending

09:16 EDT Alphatec announces commercial launch of InVictus spinal fixation platform - Alphatec Holdings announced the commercial release of InVictus, a comprehensive spinal fixation platform designed to address a range of pathologies through a minimally invasive, open, or hybrid surgical approach. With the introduction of the InVictus systems, ATEC has launched seven of twelve products planned for 2019.

09:11 EDT Liquid Media says 'confident' Gaming Division is 'positioned for success' - Liquid Media Group delivered a quarterly update for shareholders. The company said, "It has been said that we are living in "a golden age for video games," and as we take stock of the current market, we see it's with good reason. Today, there is a worldwide audience of 2.4V gamers spanning multiple generations, giving rise to soaring revenue projections for 2019 of $152B/ Add to this the game industry's move to the cloud, expected to create enormous growth potential for companies operating in this market, as well as the promise of Google Stadia launching in November and Apple Arcade in Fall 2019. Given these undeniable developments, we feel confident that Liquid's Gaming Division is positioned for success...Liquid continues to build out our gaming division, executing on our dual strategy of publishing our own IP and licensing established brands to publish across gaming platforms. The Company currently has upwards of 15 games sold across platforms garnering favorable profit share, two mobile games in partnership with A+E Networks - Ancient Aliens: The Game and Knightfall: Rivals with 50/50 profit participation, and our upcoming original game Coba: Tale of the Moon, nearing release. Work is also continuing on our Retro Reboot Initiative with Miss Kwirk, the follow-up to the popular 1990s game Kwirk, and further developing our IP library of over 200 titles. Liquid is primed to explore opportunities for developing third-party publisher relationships presented by the aforementioned Google Stadia and Apple Arcade coming online, along with other paradigm-shifts in the industry. As noted in our milestones above, Liquid has developed an array of strategic partnerships. We are building upon the strength of our alliances and continue to grow our network, thereby enhancing Liquid's offerings and expanding our reach. In the gaming space, we will continue to identify talented developers with great designs and establish partnerships; our ultimate aim is to bring these stories to life across media, including television, film, streaming and VR. As we move forward, our Studio-as-a-Service offerings are driving our push into what we see as the next generation of the content creation pipeline. We are excited to leverage the industry leading capabilities of the StratusCore platform and the cloud hosting capabilities of Open NuAge."

09:08 EDT CyrusOne promotes Bill Williams to CIO - CyrusOne announced it has promoted Bill Williams to chief information officer, or CIO. Formerly VP of Network Services, Bill Williams has helped transform the company's technology offerings, including establishing CyrusOne's IX and connectivity capabilities since joining the company in 2012. Williams has worked with various layers of the network. Prior to joining CyrusOne in 2012, Williams most recently served as VP of IP infrastructure for Terremark Worldwide, where he was responsible for the global IP network infrastructure teams, including IP transit, peering and hosting/cloud/data center platforms.

09:06 EDT Medtronic requests approval of non-adjunctive labeling from FDA - Medtronic announced its Premarket Approval submission to the U.S. Food and Drug Administration requesting approval for non-adjunctive labeling for its Guardian Sensor 3, as part of the MiniMed 670G system. If the FDA approves a sensor with non-adjunctive labeling, it means that a sensor is accurate enough to be used to calculate an insulin dose for meals and to correct high glucose levels. Since Medicare requires a non-adjunctive label for sensor reimbursement, if approved, this labeling could broaden patient access by allowing for Medicare coverage of the world's first and still the only commercially available hybrid closed loop system. The MiniMed 670G system is being used by more than 180,000 people, and the associated data on nearly 8 million patient days shows an average Time in Range of 71% across all age groups, which mirrors the pivotal trial data published in the Journal of the American Medical Association. Importantly, the clinical data meets the goals outlined in the Time in Range consensus guidelines recently published at the American Diabetes Association meeting. Overnight, when many individuals with diabetes worry about lows, MiniMed 670G system data shows Time in Range of 78% in a real-world environment, with less than 0.5% in the low ranges less than54 mg/d.

09:02 EDT La Jolla receives orphan drug designation from FDA for LJPC-0118 - La Jolla Pharmaceutical Company announced that the US Food and Drug Administration has granted an Orphan Drug Designation for the Investigational Drug Product, LJPC-0118, for the treatment of malaria. La Jolla plans to file a New Drug Application with the FDA in the fourth quarter of 2019 for LJPC-0118. The active pharmaceutical ingredient in LJPC-0118, artesunate, was demonstrated to be superior to quinine in reducing mortality in patients with severe falciparum malaria infection in two randomized, controlled, clinical studies.

09:00 EDT Fly Intel: Pre-market Movers - UP AFTER EARNINGS: Coca-Cola (KO), up 3%... United Technologies (UTX), up 2%... Quest Diagnostics (DGX), up 5%... Sherwin-Williams (SHW), up 2.5%... Lockheed Martin (LMT), up 1.5%... JetBlue (JBLU), up 1%. ALSO HIGHER: Chiasma (CHMA), up 22% after the company's pivotal Phase 3 OPTIMAL clinical trial met its primary and secondary endpoints... Realogy (RLGY), up 22% after announcing a collaboration with Amazon (AMZN) for the launch of TurnKey, a new homebuying program. DOWN AFTER EARNINGS: Centene (CNC), down 2%... Harley-Davidson (HOG), down 3%... Tile Shop (TTS), down 5%... Zions Bancorp (ZION), down 7%. LOWER: Acadia (ACAD), down 13% after reporting that its Phase 3 ENHANCE study did not achieve statistical significance.

08:58 EDT BRP Inc. completes increase to its Term Facility - BRP announced that in connection with its previously announced intention to increase the size of its term facility, it has completed today certain amendments to the agreement governing its existing US dollar-denominated term facility. The amendments provide for a new $335M tranche of term loans for a total amount of term loans outstanding as of today of $1,228,250,000. The new term loan tranche bears interest at a rate of 250 basis points over LIBOR, with a LIBOR floor of 0 basis points. The proceeds of the new term loan tranche of $335M are expected to be used to fund the substantial issuer bid completed today, pay related fees and expenses and for general corporate purposes. The term facility maturity remains unchanged at May 23, 2025.

08:57 EDT Reis & Ivry's soft serve robotic kiosks aprproved by CDPH - Generation Next announced that Reis & Irvy's unattended soft serve kiosks were approved by the California Department of Public Health for a variance that allows them to operate in the state of California. The Company has been working with CDPH to obtain this variance for almost a year. Approval to operate in California comes with specific and important requirements. The most significant is the use of the Hydra Rinse Mobile System for cleaning and sanitizing. This cleaning system replaces the 24-hour cleaning schedule requirement in California, with a schedule that allows operators to service their kiosks once every 72 hours. In addition, operators will find the length of time it takes to fully service their units is cut in half. Other operational specifications include, strict adherence to standard operating procedures and corrective action plans, partnership with an accredited food testing laboratory for quarterly bacteriological testing, and the implementation of a robust Quality Assurance Plan. This action by CDPH opens the doors for Generation Next and its franchise owners in California to move ahead on licensing with the California Department of Food and Agriculture and getting the county health permits required to begin installing Reis & Irvy's robots in sites across the state.

08:56 EDT American Midstream Partners trading halted, news dissemination

08:53 EDT Hammer, LivePerson announce integration to provide conversational commerce - Hammer Fiber Optics Holdings Corp's announced that it will provide its customers conversational communication and digital commerce services in collaboration with LivePerson. Hammer will begin to offer LiveEngage to its retail customers, and LivePerson will leverage Hammer's worldwide SMS network to expand its messaging distribution capabilities.

08:44 EDT Coca-Cola says will look to sell stake in Africa bottler 'at the right time' - CEO James Quincey says will look to sell stake in Coca-Cola Beverages Africa "at the right time to the right buyer."

08:42 EDT United Technologies says Rockwell Collins 'continues to exceed expectations' - Says: Sees Raytheon acquisition immediately accretive and 20c-30c adjusted EPS accretion in 2021... Sees ~$1B in gross cost synergies by year four...Sees ~$18B-$20B return of capital to shareholders over three years. Comments taken from Q2 earnings conference call.

08:41 EDT Coca-Cola expects to have Coke Energy available in 20 markets by end of 2019

08:40 EDT Envision Solar appoints Katherine McDermott as CFO - Envision Solar International announced that Katherine McDermott has joined the executive team as CFO. Prior to her appointment at Envision Solar, she was the CFO for Steico Industries, a subsidiary of global aerospace company Senior

08:38 EDT Obalon Therapeutics enters into commercial lease for retail weight loss center - Obalon Therapeutics announces that it has entered into a commercial lease for its first Company-owned weight loss center. As part of a strategy to increase patient access and utilization of its novel gastric balloon weight loss system, Obalon intends to own and operate a network of retail centers throughout the United States that focus solely on patients wishing to lose weight using the Obalon Balloon System. The first Obalon retail center will be located in San Diego and the Company is targeting this fall for its grand opening.

08:35 EDT Funko appoints Jennifer Fall Jung as CFO - Funko (FNKO) announced the appointment of Jennifer Fall Jung as CFO, effective August 13, 2019. Fall Jung will succeed Russell Nickel, whose planned departure was previously announced on April 16, 2019. Fall Jung brings over 20 years of experience in financial and executive leadership roles at Gap, (GPS), most recently serving as SVP, Corporate Finance and Investor Relations.

08:32 EDT Ideanomics announces strategic partnership with Palcan Energy - Ideanomics has announced a strategic partnership with Shanghai Bo Hydro New Energy Technology, known in English as Palcan Energy, a Methanol to Hydrogen energy provider which is joint headquartered in Vancouver, Canada and Shanghai, China. The purpose of the partnership is to introduce Palcan's Methanol to Hydrogen technology to existing fuel station networks, as an efficient way to roll-out a fast-charging network for EV that is both familiar and accessible to consumers and fleet customers. The partnership plans to begin building out fast charge networks, as part of Ideanomics' innovative S2F2C model, by partially or fully converting existing fossil fuel gas stations into fast-charging new energy stations, giving the major fossil fuel companies a convenient path to ensuring their fuel stations are converted rather than disposed of or abandoned during the migration to clean tech fuels.

08:28 EDT Just Energy announces adjustment of accounts receivable - Just Energy Group announced that as part of the previously announced Strategic Review process, management identified customer enrollment and non-payment issues, primarily in Texas, over the past 12 months. As management identified these issues, more robust operational controls were put in place, culminating in numerous improvements being implemented during June and July 2019. Due to the identified issues, management is updating its provisioning methodology used to estimate its reserve for trade receivables. Management expects an incremental impairment of the Texas residential accounts receivable of approximately C$45M to C$50M as of June 30, 2019. "The enrollment and non-payment issues have been remediated and management is confident in the business and operational controls currently in place. These issues will not have a continuing effect on future cash flows," said Rebecca MacDonald, Just Energy's Executive Chair. "The Strategic Review is ongoing."

08:26 EDT Syapse announces collaboration with Pfizer in oncology precision medicine - Syapse announced that it has entered into a strategic collaboration with Pfizer to advance cancer outcomes research using real-world evidence toward the ultimate goal of improving patient health. This collaboration will initially focus on the molecular testing and therapy choices on precision oncology journeys in the healthcare system setting.

08:18 EDT Spring Bank Pharmaceuticals announceds dosing of inarigivir in HBV studies - Spring Bank Pharmaceuticals announced dosing of patients with inarigivir soproxil 400mg in two significant trials: the CATALYST 2 trial, examining the administration of inarigivir 400mg in nucleoside-suppressed chronic hepatitis B virus patients, and a unique liver biopsy study examining paired liver biopsies in HBV patients before treatment and on treatment with inarigivir to identify the interaction of inarigivir 400mg with the intrahepatic immune system and its effect on cccDNA. Spring Bank also announces the expansion of a collaborative study in patients infected with chronic HBV involving the evaluation of multiple doses of inarigivir co-administered with tenofovir alafenamide 25mg to include the 400mg dose of inarigivir. Spring Bank's broad phase 2 HBV clinical development program is designed to demonstrate the likelihood of functional cure in both HBV treatment-naive and HBV suppressed patients on nucleotide treatment in the CATALYST 1 and CATALYST 2 trials, leading to the potential to initiate inarigivir Phase 3 studies in late 2020. Spring Bank anticipates that it will begin dosing patients in the CATALYST 1 trial, a study examining the use of inarigivir 400mg as monotherapy and co-administered with tenofovir alafenamide 25mg daily in HBV treatment-naive patients, in September. The principal investigator has successfully randomized and completed treatment in the first patient in the intra-hepatic liver biopsy study. This trial will evaluate both the immunology and virology of HBV directly in the liver and the corresponding response to inarigivir. "This exciting and unique study has the potential to determine how activating the innate immune system with inarigivir can reduce intra-hepatic viral burden and cccDNA reservoirs and is a critical scientific study for understanding the pathway to HBV cure," said Dr. Antonio Bertoletti, a member of the Spring Bank Scientific Advisory Board and the Principal Investigator of the study at Duke-NUS Medical School in Singapore. Additionally, the ongoing collaborative trial examining multiple ascending doses of inarigivir co-administered with tenofovir alafenamide 25mg for 12 weeks has been expanded to include a new cohort of chronic HBV patients receiving inarigivir 400mg daily with tenofovir alafenamide 25mg daily.

08:14 EDT MJardin Group receives transfer of license agreement for Nevada facility - MJardin Group announced it has successfully closed and received the ownership transfer of license for its Cheyenne Ave., Las Vegas, Nevada cultivation facility from GreenMart of Nevada, providing the Company with its first 100% owned and operated cultivation facility in Nevada. As a result of this transaction MJardin now owns the license to cultivate medical and recreational cannabis at its Las Vegas facility. This transfer agreement marks a big step in the Company's 2019 strategy as it continues to successfully develop across the cannabis value chain in the Nevada market. The cultivation within this facility lends itself to future value-add opportunities with MJardin's sister asset, Cannabella, an edible and topical production facility with extraction capabilities, that currently has products in 50 out of 65 retail locations in Nevada. The transfer of ownership from Cannabella to MJardin is expected to close third quarter 2019. The 30,000 sq. ft. facility is expected to have 16,000 sq. ft. of bench space with 5,700 kg product/year at full capacity by early Q3 2020.

08:11 EDT BRP Inc. announces completion of substantial issuer bid - BRP announced that it has taken up and paid for 6,342,494 subordinate voting shares at a price of C$47.30 per Share under BRP's substantial issuer bid to purchase for cancellation a number of its Shares for an aggregate purchase price not to exceed C$300M. The Shares purchased represent an aggregate purchase price of approximately $300M and represented 6.6% of the total number of BRP's issued and outstanding Shares and multiple voting shares as of July 22, 2019. After giving effect to the SIB, BRP will have 39,289,683 Shares and 50,861,671 multiple voting shares issued and outstanding. A total of 3,102,768 Shares were taken up and purchased pursuant to auction tenders at or below the purchase price and purchase price tenders. Since the SIB was oversubscribed, shareholders who made auction tenders at or below the purchase price and purchase price tenders had approximately 95.8% of their successfully tendered Shares purchased by BRP. 3,239,726 Shares were taken up and purchased pursuant to proportionate tenders.

08:08 EDT Lockheed Martin boosts FY19 segment operating profit view to $6.325B-$6.475B - Previous view was $6.1B-$6.25B. By segment, FY19 sales are expected to be: $23.25B-$23.75B for Aeronautics vs. prior view of $22.95B-$23.45B; $14.7B-$15.1B for RMS vs. prior view of $14.35B-$14.75B; $10.5B-$10.8B for Space vs. prior view of $9.85B-$10.15B; $9.8B-$10.1B for MFC vs. prior view of $9.6B-$9.9B. By segment, FY19 operating profit is expected to be: $2.475B-$2.525B for Aeronautics vs. prior outlook of $2.45B-$2.5B; $1.335B-$1.375B for RMS vs. prior view of $1.315B-$1.355B; $1.1B-$1.13B for Space vs. prior outlook of $960M-$990M; $1.415B-$1.445B for MFC vs. prior outlook of $1.375B-$1.405B. Comments taken from slides being presented on the Q2 earnings conference call.

08:06 EDT Amira Nature Foods expects to sell over $12M of edible oils in FY20 - Amira Nature Foods announced that its edible oils business has sold over $4M of product since April 1, the beginning of the company's fiscal year. The edible oils, which consists mainly of palm oil, were sold via Amira branded product and third party branded oils to customers, mainly in the Middle East. The company expects to sell over $12M of edible oils in the fiscal year ending March 31, 2020.

08:04 EDT Equinix strengthens relationship with Amazon Web Services - Equinix (EQIX) announced it is strengthening its relationship with Amazon Web Services (AMZN) to offer enhanced cloud connectivity that helps enterprises accelerate their journey to AWS via a private cloud network onramp. Building upon its existing collaboration to offer private and secure connectivity with AWS Direct Connect, Equinix is participating in the launch of the new AWS Direct Connect Service Delivery Program, which allows Equinix customers to use Hosted Connections with 1G, 2G, 5G and 10G capacities on Equinix Cloud Exchange Fabric. The enhanced capabilities allow enterprises with mission-critical workloads to benefit from lower latency and higher bandwidth capacities for hybrid cloud architectures on Platform Equinix.

08:03 EDT Genpact extends relationship with IRI - Genpact announced that it is extending its relationship with IRI, a global leader in innovative solutions and services for consumer, retail, and media companies, building on more than a decade of working together. As part of the multi-year agreement, Genpact will continue to provide operations and automation services and analytics support to help IRI in its overall efforts to efficiently deliver augmented intelligence from purchase, point-of-sale, promotional, loyalty, demographic, and additional consumer data. These solutions help IRI's clients optimize pricing and promotions, model markets, and segment customers to win market share and accelerate growth.

08:00 EDT Marinus Pharmaceuticals trading resumes

07:50 EDT Vislink receives orders valued at $1.6M for satellite communications equipment - Vislink Technologies announced that it has received orders valued at approximately $1.6M from global clients for its industry-leading satellite communications equipment. The organizations clients include organizations in broadcast and MilGov markets.

07:48 EDT Marathon Patent Group receives Nasdaq acceptance of plan to regain compliance - Marathon Patent Group announced that today that The Nasdaq Stock Market has accepted the company's plan to regain compliance with Nasdaq Listing Rule 5250(c)(1), which acceptance will permit the continued listing of Marathon's common stock on the Nasdaq Capital Market. As previously reported, on May 21, 2019, Marathon Patent Group received notice from the Nasdaq Capital Market that the Company has failed to maintain a minimum of $2,500,000 in stockholders' equity for continued listing as required under Listing Rule 5550(b)(1) as its Form 10-Q for the period ended March 31, 2019 reported stockholders' equity of $2,158,192. Under the Capital Market's Rules, the Company has 45 calendar days to submit a plan to regain compliance, and if the plan is accepted, the Capital Market can grant an extension of up to 180 calendar days from the date of the notice to evidence compliance. On June 29, 2019, the Company timely submitted to Nasdaq a plan to regain compliance with the Rule. After reviewing the company's plan, Nasdaq accepted the plan and granted an exception to enable the company to regain compliance with the Rule. Under the terms of the exception, the company is required to file the Form 10-Q for the period ending September 30, 2019 with the SEC on or before November 13, 2019 evidencing compliance with the stockholders' equity requirement. Nasdaq has advised the company that a failure to file the Form 10-Q within the extension period may result in a notice of delisting of the company's common stock.

07:45 EDT Marinus Pharmaceuticals announces data from Phase 2 Amaryllis study - The Amaryllis Study enrolled patients with a baseline HAM-D17 score of 25.5 for the low dose group and 25.4 for the high dose group. In this open-label dose-optimization study, 25 patients received 675 mg of oral ganaxolone at dinner for 28 days and 43 patients received 675 mg of oral ganaxolone at dinner and bedtime for two days, followed by a dinner time dose of 1125 mg once daily for the remainder of the 28-day treatment regimen. The low dose showed a mean HAM-D17 reduction from baseline of 0.8, 9.8, and 12.2 at 24 hours of treatment at 14 and 28 days of treatment, respectively, and the high dose showed a mean HAM-D17 reduction of 2.7, 9.3 and 14.5 at 24 hours of treatment at 14 and 28 days of treatment, respectively. The high dose showed a HAMD-17 reduction at 24 hours of treatment that was 2.0 points greater than the low dose, which was generally sustained over the treatment regimen, suggesting an efficacy trend with early activity onset. Oral ganaxolone was generally safe and well-tolerated with no serious adverse events reported and no discontinuations due to treatment related adverse events. Data from the Amaryllis Study support continued use of the once daily 1125 mg oral dose in future clinical studies. The Company will continue to engage strategic interest in oral ganaxolone and believes that the Amaryllis data would potentially be the basis of a constructive partnership.

07:41 EDT RedHill Biopharma continues to enroll patients in Phase 2a study of YELIVA - The ongoing Phase 2a study evaluating the activity of orally-administered YELIVA in advanced cholangiocarcinoma continues to enroll patients in the second stage of the two-stage study design. Enrollment of the full cohort of 39 evaluable patients is expected to be completed by the end of 2019.

07:39 EDT RedHill Biopharma to initiate Phase 3 study activities with RHB-204 in Q4 - RedHill plans to initiate pivotal Phase 3 study activities with RHB-204 for the treatment of pulmonary NTM infections in the fourth quarter of 2019, subject to completion of the ongoing supportive non-clinical program and additional input from the FDA. The study is intended to assess the efficacy and safety of RHB-204 and potentially support its approval as a stand-alone, first-line treatment for Mycobacterium avium complex disease, the most common cause of pulmonary NTM infections.

07:38 EDT RedHill Biopharma plans U.S. launch of Talicia in 4Q19 - The U.S. Food and Drug Administration has accepted for priority review the NDA for Talicia for H. pylori infection. The NDA for Talicia was assigned a target Prescription Drug User Act action date of November 2, 2019. If approved, Talicia would be eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product designation, in addition to patent protection extending until at least 2034. Assuming FDA approval, RedHill plans to launch Talicia in the U.S. in the fourth quarter of 2019 with the Company's established sales force, led by RedHill's highly experienced commercial management team. The Company further strengthened its commercial management team in the second quarter of 2019 including several key executive hires.

07:36 EDT Myovant Sciences says primary efficacy endpoint met in LIBERTY 2 study - Myovant Sciences announced that LIBERTY 2, the second of two Phase 3 studies of once-daily relugolix combination therapy, met its primary efficacy endpoint and six key secondary endpoints in women with uterine fibroids. In addition, relugolix combination therapy maintained bone mineral density at levels comparable to placebo over 24 weeks and was generally well- tolerated. These results confirm the previously announced data from the Phase 3 LIBERTY 1 study and enable an NDA submission to the U.S. Food and Drug Administration by the end of this year. Myovant Sciences also announced that a separate clinical study of single-tablet relugolix combination therapy met all required and pre-specified FDA criteria for bioequivalence, providing critical data necessary to include the once-daily, single-tablet regimen in the NDA submission for approval of the treatment for uterine fibroids. The single-tablet regimen is the formulation intended to be offered to women should relugolix combination therapy receive FDA approval. In the primary endpoint analysis of LIBERTY 2, 71.2% of women receiving once-daily relugolix combination therapy achieved the responder criteria compared with 14.7% of women receiving placebo. A response was defined as a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction from baseline in menstrual blood loss volume during the last 35 days of treatment measured using the alkaline hematin method. On average, women receiving relugolix combination therapy experienced a highly significant 84.3% reduction in menstrual blood loss from baseline. In addition, a significantly greater proportion of women suffering from moderate-to-severe pain from uterine fibroids at baseline experienced no pain or minimal pain during the last 35 days of treatment with relugolix combination therapy compared with women on placebo. Changes in bone mineral density were comparable between the relugolix combination and placebo groups at the end of treatment. The distribution of the change in bone mineral density, including outliers, was similar for the relugolix combination therapy and placebo groups at 24 weeks, as assessed by dual energy x-ray absorptiometry. Six key secondary endpoints achieved statistical significance compared to placebo, consisting of mean change in menstrual blood loss from baseline to week 24, reduction in pain in women with pain at baseline, improvement in quality of life, amenorrhea, defined as no or negligible blood loss, improvement in anemia in those women with anemia at baseline, and reduction in uterine volume. The overall incidence of adverse events in the relugolix combination and placebo groups was comparable. In the relugolix combination therapy group, 1.6% of women discontinued treatment early due to adverse events compared with 4.7% in the placebo group. There were no adverse events in the relugolix combination group reported by at least 10% of women and more frequently than in the placebo group. The incidence of hot flashes in the relugolix combination group was similar to placeb). There were no pregnancies in the relugolix combination group and one in the placebo group.

07:34 EDT Cytokinetics granted European orphan designation for reldesemtiv - Cytokinetics Incorporated (CYTK) announced that the European Medicines Agency has granted orphan medicinal product designation to reldesemtiv for the potential treatment of spinal muscular atrophy. The U.S. Food and Drug Administration previously granted orphan drug designation to reldesemtiv for the potential treatment of SMA in 2017. In collaboration with Astellas (ALPMY), Cytokinetics is developing reldesemtiv, a fast skeletal muscle troponin activator, as a potential treatment for people with SMA and certain other debilitating diseases and conditions associated with skeletal muscle weakness and/or fatigue.

07:30 EDT WeedMD launches cannabis extraction affiliate CX Industries - WeedMD announced it has launched CX Industries, a wholly-owned subsidiary that will specialize in extraction, toll processing and third-party product formulation from WeedMD's fully-licensed Aylmer, Ontario facility. CX Industries will have the capacity to process more than 200,000 kgs of biomass at its peak production in 2020. The Company recently announced the transition of its Aylmer, Ontario facility, now CX Industries, into a large-scale cannabis extraction and processing hub. Together with its greenhouse cultivation and outdoor grow that is in full operation at its Strathroy facility, WeedMD is producing significant low-cost biomass input for extraction.

07:26 EDT Nasdaq signs new agreement with Football Index - Nasdaq announced it has signed a new agreement with Football Index, where clients can buy and sell shares in professional footballers, and will provide the company with a flexible, cloud-optimized trading engine that offers rich functionality. As part of the Nasdaq Financial Framework offering, Football Index will join a growing list of new markets outside of financial services that are relying on Nasdaq's marketplace technology to accelerate their business growth and enhance the client experience.

07:21 EDT Internap launches Intelligent Monitoring managed cloud and monitoring service - Internap Corporation announced the general availability of Intelligent Monitoring, a premium managed cloud and infrastructure monitoring service. Optimized now for Bare Metal customers, Intelligent Monitoring is delivered via INAP INblue, the company's new infrastructure management and support platform for cloud products. Intelligent Monitoring was designed to combine the best elements of advanced monitoring software with a proactive and transparent support experience. The technology comprehensively tracks and measures the health of the customer's server environment, including hardware, resources, applications, and OS services for Linux and Windows. INAP support technicians immediately remediate identified issues via a proprietary, software-defined Smart Workflow System. Throughout the process, customers are updated via the INAP INblue desktop and iOS mobile application, where they can track INAP's progress, review metric and log data, and communicate with assigned technicians from a single screen.

07:18 EDT Applied Genetic completes enrollment of third group in Phase 1/2 clinical study - Applied Genetic Technologiesannounced that it has completed enrollment of the third group in the dose escalation portion of its Phase 1/2 clinical trial evaluating the safety and efficacy of subretinal injection of for the treatment of achromatopsia caused by mutations in the CNGA3 gene. AGTC is enrolling patients in two parallel Phase 1/2 clinical trials of its product candidates for ACHM caused by mutations in the two most common ACHM genes, CNGB3 and CNGA3. The primary focus of the ACHM trials is assessing the safety of the vector and subretinal delivery procedure through analysis of focal and systemic treatment-emergent adverse events. Safety will be monitored by evaluation of ocular and non-ocular adverse events. In addition, each trial will measure biologic activity by assessing changes in a wide number of measures of visual function, including visual acuity, light sensitivity, color vision, and quality of life. The company expects to provide interim dose-escalation data from both trials in the fourth quarter of 2019.

07:10 EDT Mustang Bio treatment of acute myeloid leukemia granted FDA orphan status - Mustang Bio's treatment of acute myeloid leukemia was granted FDA orphan status, according to a post to the agency's website. Reference Link

07:09 EDT Interpublic Group remains on track to deliver 2%-3% organic growth - Michael Roth, Interpublic's Chairman and CEO, said, "At mid-year, we are confident that our performance to date and the current tone of the business have us on track to deliver growth at the high end of the 2-to-3% organic growth target set at the beginning of the year. In addition, we continue to be comfortable with our target for adjusted EBITA margin expansion of 40-50 basis points over last year's 13.5%. We view our current performance and long-term strategy as the basis for significant shareholder value creation."

07:08 EDT Iridium sees FY19 service revenue $440M - Sees FY19 OEBITDA $325M-$335M in 2019; OEBITDA for 2018 was $302.0M; and negligible cash taxes in 2019. Cash taxes are expected to be negligible through approximately 2023. Net leverage of approximately 4.5x OEBITDA at the end of 2019.

07:04 EDT Coca-Cola sees FY19 cash from operations at least $8.5B - Sees FY19 CapEx approximately $2.4B.

07:00 EDT Harley-Davidson cuts FY19 shipment view to 212,000-217,000 from 217,000-222,000 - Sees FY19 motorcycles segment operating margin as a percent of revenue to be approximately 6%-7%. Sees FY19 capital expenditures $225M-$245M.

06:54 EDT TransUnion says TransUnion Limited victim of criminal fraud - "On July 12, 2019, the company determined that TransUnion Limited, a Hong Kong entity in which the Company holds a 56.25 percent interest, has been the victim of criminal fraud. The incident involved employee impersonation and fraudulent requests targeting TransUnion Limited, which resulted in a series of fraudulently-induced wire transfers in early July 2019 totaling $17.8 million. The company has launched an internal investigation to determine the full extent of the fraud scheme and related potential exposure, and expects to record a one-time pre-tax charge of up to $17.8 million in the third quarter of 2019 as the result of this event. The Company self-discovered this fraudulent activity and promptly initiated contact with its bank as well as appropriate law enforcement authorities. The Company may be limited in what information it can disclose because of the ongoing investigation. To date, the Company has not found any evidence of additional fraudulent activity. This incident did not result in any unauthorized access to any of the confidential consumer information or other data that we maintain. While this matter will result in some additional near-term expenses, the Company does not expect this incident to otherwise have a material impact on its business."

06:47 EDT Merck and Eisal announce FDA granted Breakthrough designation for KEYTRUDA - Merck and Eisai announced that the FDA has granted Breakthrough Therapy designation for KEYTRUDA, Merck's anti-PD-1 therapy, in combination with LENVIMA, the orally available kinase inhibitor discovered by Eisai, for the potential first-line treatment of patients with advanced unresectable hepatocellular carcinoma not amenable to locoregional treatment. This is the third Breakthrough Therapy designation for the KEYTRUDA plus LENVIMA combination and is based on updated interim results from the Phase 1b trial KEYNOTE-524/Study 116.

06:44 EDT GNC Holdings says expects to end up closer to top end of 700-900 store closures - GNC Holdings, on its Q2 earnings conference call on Monday, said it expects to end up closer to the top end of its original optimization estimate of 700 to 900 store closures. The company said it is likely to reduce its mall count by "nearly half," adding that "we've got a little over 800 malls today and, over the long-term, it could bring that closer to 400 to 500."

06:43 EDT PulteGroup CEO says 'optimistic about housing demand' through remainder of year - "PulteGroup's second quarter results demonstrate our ongoing success in running a highly profitable, high returning business, with a clearly articulated approach to capital allocation," said Ryan Marshall, President and CEO of PulteGroup. "Consistent with our stated objectives, our continued strong operating performance allowed us to invest over $850 million in total land spend in the quarter, while also using almost $400 million of available cash for dividends, share repurchases and debt reduction." "As reflected in our results, consumer activity remains high as homebuyers are returning to the market following a period of softer demand in the back half of 2018," added Marshall. "Given the low interest rate environment, in combination with supportive economic, employment and demographic trends, we are optimistic about housing demand as we advance through the remainder of 2019."

06:38 EDT Premier partners with Exela Pharma Sciences through its ProvideGx program - Premier, through its ProvideGx program, has partnered with Exela Pharma Sciences, to supply sodium bicarbonate injection to healthcare providers, a drug that has been in shortage in the U.S. for nearly two years. Sodium bicarbonate injection is most commonly used for urgent treatment of cardiac emergencies, such as cardiac arrest, heart attacks, strokes and other life-threatening emergencies. The financial terms of Premier's agreement for sodium bicarbonate injection were not disclosed. Revenues from this agreement are not expected to materially impact Premier FY20 results.

06:38 EDT KeyCorp sees FY19 net interest income $4B-$4.1B, noninterest income $2.5B-$2.6B - In slides being presented on its Q2 earnings conference call, KeyCorp forecast FY19 loans with average balances in the $90B-$91B range and deposits with average balances in the $108B-$109B range. Net interest income is expected to be $4B-$4.1B, and KeyCorp said this outlook assumes one 25bp interest rate decrease. Noninterest income is expected to be $2.5B-$2.6B and non interest expense is seen at $3.85B-$3.95B, including the realization of $200M in run-rate cost savings in 2H19. Net charge-offs are expected to average loans below the targeted range of 40-60bps, with provisions expected to slightly exceed net charge-offs. KeyCorp sees a GAAP tax rate in the 18%-19% range.

06:36 EDT California Resources and Colony Capital form strategic joint venture - California Resources (CRC) and Colony Capital (CLNY) through its energy investment management arm, Colony HB2 Energy, announced that they have formed a strategic joint venture in which Colony has committed to fund $320M for the development of CRC's flagship Elk Hills field, located in the San Joaquin Basin. Subject to the mutual agreement of the parties, the total investment may be increased to $500M. The initial investment commitment will cover multiple development opportunities throughout the Elk Hills field and is intended to be invested over approximately three years in accordance with a pre-approved development plan consisting of approximately 275 wells. Colony will fund 100% of the development wells and will earn a 90% working interest. CRC's working interest will revert from 10 to 82.5% upon Colony achieving an agreed upon return. Colony will also receive warrants to purchase up to 1.25M shares of common stock with a $40 strike price upon funding their capital obligations.

06:33 EDT Hasbro CEO says 'we delivered a high-quality second quarter' - "We delivered a high-quality second quarter, with positive consumer trends at retail and profitable growth led by several geographies and brand categories," said Brian Goldner, Hasbro's chairman and CEO. "Our investments are differentiating Hasbro's portfolio and delivering profitable revenue streams, including continued MAGIC: THE GATHERING revenue growth in tabletop and digital. We grew revenues in the U.S. and Europe, and we believe we are well-positioned to deliver against our target of profitable growth for the full-year 2019."

06:28 EDT Dr. Reddy's announces launch of Ramelteon Tablets in U.S. - Dr. Reddy's Laboratories announced the launch of Ramelteon Tablets, 8 mg, a therapeutically equivalent generic version of Rozerem Tablets, approved by the U.S. FDA. The Rozerem brand had U.S. sales of approximately $91.3M MAT for the most recent twelve months ending in May 2019 according to IQVIA Health.

06:11 EDT Polaris Industries: Q2 N.American side-by-side retail sales up low single digits - North American Side-by-side retail sales increased low-single digits percent for the quarter compared to last year; Indian retail sales were down high-single digits percent, outperforming the industry and gaining share in an extremely challenging market.

06:09 EDT Popeyes to open 1,500 restaurants in China over next ten years - Popeyes Louisiana Kitchen announced an exciting new agreement to develop and open more than 1,500 Popeyes restaurants in the People's Republic of China over the next 10 years. Popeyes is the last of RBI's brands to enter the Chinese market.

06:06 EDT Polaris Industries CEO says 'worked diligently to overcome impacts of tariffs' - Scott Wine, Chairman and CEO said, "Our second quarter results reflect the deft leadership and disciplined execution of our Polaris team. We worked diligently to overcome the impacts of tariffs, a very wet spring and an aggressive promotional environment, delivering financial results slightly favorable to expectations but trailing our long-term performance goals. The strength of our industry-leading brands and vehicles enabled us to gain share in Indian Motorcycles and drive growth in Side-by-Sides with RANGER and RZR, although our decision to assume price leadership did impact volume, specifically in our lower margin youth and value segments. We are encouraged by our market share gains and year-to-date growth in Boats, as well as the continued improvement at TAP, where retail store sales growth was up nicely. Our operational and dealer fundamentals are in good shape as we head into the critically important model year 2020 product introductions, and we anticipate improved retail performance during the second half of the year. We are excited to host our unrivaled dealer network at our 65th Anniversary dealer show later this month, and look forward to demonstrating how we will continue to be the global leader in Powersports with our unwavering commitment to be a customer-centric, highly efficient growth company."

06:01 EDT Riddle & Code launches car wallet hardware with Daimler - RIDDLE & CODE, a European provider of blockchain interface solutions, has partnered with Daimler to produce a hardware wallet for automobiles. Long term, the business alliance looks to provide solutions for self-driving vehicles and car-sharing platforms, relay traffic patterns in real-time, mesh with smart city infrastructure, and transfer accident information to the proper authorities and insurance providers.

05:54 EDT SPI Energy to acquire up to 21MW of solar project portfolio in Oregon - SPI Energy announced the execution of a framework agreement to acquire up to eight solar PV projects, totaling 21MW in the State of Oregon. These solar PV projects will sell power through their respective 20-year PURPA Power Purchase Agreement with Portland General Electric, and they are expected to start construction and reach commercial operation over the next 18 months. The acquisitions are subject to customary closing conditions.

05:36 EDT Sanofi signs strategic deal with Roche for exclusive U.S. OTC rights to Tamiflu - Sanofi (SNY) signed an agreement with Roche (RHHBY) for the exclusive over-the-counter, or OTC, rights to Tamiflu for the prevention and treatment of influenza or flu in the U.S. Under the terms of the agreement, Sanofi will be responsible for leading FDA negotiations for the OTC switch and subsequent exclusive marketing, scientific engagement and distribution of Tamiflu OTC in the US. Tamiflu is currently sold in the U.S. by Genentech, a member of the Roche Group, for prescription use.