Stockwinners Market Radar for September 04, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

21:11 EDT Gol Linhas reports August domestic supply up 4.2% - GOL Linhas Aereas Inteligentes S.A. announces preliminary air traffic figures for the month of August 2019. GOL's domestic supply, or ASK, increased 4.2% and demand, or RPK, increased by 11.2%. GOL's domestic load factor was 83.2%, a 5.2pt increase in comparison to August 2018. The volume of departures increased by 7.0% and seats increased by 7.6% over August 2018. GOL's international supply and demand increased by 53.4% and 72.5% respectively, and international load factor was 77.0%, an increase of 8.6 p.p. in relation to August 2018. GOL's total supply was 9.5% higher due to a 9.3% increase in seats and a 9.0% increase in departures. GOL's total demand increased by 17.1% in comparison to August 2018 and consolidated load factor was 82.3%.

21:08 EDT Kayne Anderson MLP reports net assets $2.0B as of August 31 - Net asset value per share was $15.67

18:58 EDT Coty chairman buys 1.05M shares of common stock - In a regulatory filing, Coty disclosed that its chairman Peter Harf bought 1.05M shares of common stock on August 30th-September 3rd. The total transaction size was $9.98M.

18:40 EDT GAP Airports reports August traffic up 8.1% - Grupo Aeroportuario del Pacifico announced preliminary terminal passenger traffic figures for the month of August 2019, compared to traffic figures for August 2018. During August 2019, total terminal passengers increased by 8.1% at the Company's 13 airports, compared to the same period of the previous year. Domestic passenger traffic increased by 8.6%, while international passenger traffic increased by 7.4%.

18:04 EDT REV Group cuts FY19 adjusted EBITDA view to $100M-$110M from $150M-$170M - Cuts FY19 revenue view to $2.35B-$2.45B from $2.4B-$2.6B, consensus $2.47B. CEO Tim Sullivan states: "Third quarter results were well below our expectations due to the performance in three of our largest business units. Looking forward, we do not expect that our new workforce in the largest Fire business unit will be sufficiently efficient through the remainder of this year as they continue to be trained and integrated into the business. Further, due to the late receipt of a large multi-year ambulance contract, we believe we will be unable to achieve these forecasted shipments and associated profitability this year. Finally, we expect the RV industry softness to continue through at least the end of fiscal 2019. Primarily as a result of these factors, we are lowering our full year guidance for fiscal 2019 revenues to $2.35 to $2.45 billion from $2.4 to $2.6 billion, net income to $(8) to $5 million from $43 to $63 million, Adjusted EBITDA to $100 to $110 million from $150 to $170 million, and Adjusted Net Income to $28 to $41 million from $66 to $84 million."

17:55 EDT General Electric awarded $143.68M Navy contract modification - General Electric was awarded $143.68M for modification to a previously awarded firm-fixed-price, cost-plus-fixed-fee contract. This modification is for 24 low rate initial production Lot 3 T408-GE-400 turboshaft engines and three Lot 2 T408-GE-400 engines for the CH-53K helicopter. In addition, this modification provides for associated engine and programmatic support, logistics support, peculiar support equipment and spares. Work will be performed in Lynn, Massachusetts and is expected to be completed in December 2022. FY18 and FY19 aircraft procurement funds in the amount of $143.68M will be obligated at time of award, none of which will expire at the end of the current fiscal year. The Naval Air Systems Command is the contracting activity.

17:37 EDT At Home Group down 17% after FY20 revenue guidance cut, below-consensus Q3 view - Shares of At Home Group are down 17% or $1.17 at $5.73 after its Q2 results, below-consensus Q3 guidance, and a cut in its FY20 forecasts for revenue and same-store sales ranges.

17:29 EDT Dynatrace down 4.1% after first results as public company - Shares of Dynatrace are down 4.1% or 99c at $22.95 after its first reported results as a public company.

17:23 EDT Slack Technologies down 14.6% after reporting first results as public company - Slack Technologies shares are down 14.6% or $4.52 at $26.49 after the company's first results as a public company, with a beat on earnings and revenue in Q2, but below-consensus outlook for Q3.

17:15 EDT Mallinckrodt plunges almost 24% after Bloomberg reports on restructuring - Shares of Mallinckrodt are down 23.85% or 62c per share to $1.98 after Bloomberg says company is in talks with restructuring firms due to opiod issues.

17:07 EDT Agios Pharmaceuticals announces new DRIVE PK data published in NEJM - Agios Pharmaceuticals announced that new data from the core and extension phases of the DRIVE PK Phase 2 study of mitapivat in adults with pyruvate kinase, or PK, deficiency were published in the September 5 issue of the New England Journal of Medicine, or NEJM. Mitapivat is an investigational, oral, small molecule allosteric activator of wild-type and a variety of mutated pyruvate kinase-R, or PKR, enzymes that directly targets the underlying metabolic defect in PK deficiency, a rare, potentially debilitating, hemolytic anemia. DRIVE PK is an ongoing global, open-label, Phase 2, safety and efficacy study evaluating mitapivat in adults with PK deficiency who do not receive regular transfusions. Patients were randomly assigned to receive either 50 mg or 300 mg of mitapivat twice daily for a 24-week core period and eligible patients could continue treatment in an ongoing extension phase. As of the August 31, 2018 data cutoff, 52 patients were randomized and 43 completed the core period. Thirty-six patients entered and 19 remain in the extension phase with a median treatment duration of 28.9 months. The median baseline hemoglobin was 8.9 g/dL. Nearly half of the patients reported a history of treatment with iron chelation despite the absence of regular transfusions, while the majority of patients had a prior splenectomy and cholecystectomy. A safety analysis conducted for all 52 treated patients as of the data cut-off shows that adverse events associated with mitapivat were mainly low-grade and transient. The cumulative safety profile remained similar to that observed in the core period and continues to support long-term twice daily dosing. The majority of adverse events, or AEs, were Grade 1-2; the most frequent were headache, insomnia and nausea. These events resolved within seven days after the initiation of treatment in 92% of episodes of headache, 47% of episodes of insomnia and 78% of episodes of nausea. Nine patients experienced Grade 3 treatment-related adverse events: hypertriglyceridemia, hemolytic anemia and hemolysis, dizziness, headache, left renal cell carcinoma and insomnia. Changes from baseline in sex hormone levels were observed in men, the result of mild off-target aromatase inhibition, with most values of testosterone and estradiol remaining within the normal range. Interpretation of sex hormone data in females was confounded by variability in menopausal status and hormonal contraception use and will be assessed further in the Phase 3 studies. In the efficacy analysis, 26 of 52 patients achieved a clinically significant maximum hemoglobin increase of greater than1.0 g/dL in the core period with improvement in other markers of hemolysis as of the data cutoff. In patients who had hemoglobin increases of greater than1.0 g/dL in the core period, the mean maximum hemoglobin increase was 3.4 g/dL. The median time to first hemoglobin increase of greater than 1.0 g/dL was 10 days. Twenty patients maintained a hemoglobin response greater than 1.0 g/dL for greater than 50% of assessments in the core period. The hemoglobin response was maintained in 19 patients who continued to be treated in the extension phase, all of whom had at least 21.6 months of treatment. In the patients with a hemoglobin response, directionally appropriate changes over time in absolute reticulocytes counts, indirect bilirubin, haptoglobin and lactate dehydrogenase provide additional evidence of decreased hemolysis with mitapivat treatment. Agios has two ongoing global, pivotal trials in adults with PK deficiency that are on track to complete enrollment by year end.

17:02 EDT Logitech elects Wendy Becker as new chairperson, raises dividend by 10% - Logitech announced that at its annual general meeting the company's shareholders elected Wendy Becker as Logitech's new chairperson. This followed an earlier decision by Guerrino De Luca to remain on the board if re-elected, but not to stand for re-election as chairperson when his term ended. Additionally, at the meeting, Logitech's shareholders approved a dividend of approximately CHF0.73 per share, an increase of approximately 10% compared to last year.

16:53 EDT NexPoint Residential did not sustain material damage from Hurricane Dorian - NexPoint Residential announced that the company's apartment communities located throughout Florida, including the newly acquired Pembroke Apartments, continue to have stabilized occupancies and as of the time of this release, have not sustained any material damage. The company plans to provide additional updates in the event of a material change.

16:45 EDT Thirdpoint lowers activist stake in Campbell Soup to 5.74% from previous 6.98% - Thirdpoint lowered its activist stake in Campbell Soup in Campbell Soup to 5.74%, which represents 17,3M shares from previous 6.98% stake. This filing allows for activism.

16:42 EDT Palo Alto Networks down over 6% after below-consensus Q1 and FY20 guidance

16:36 EDT Cherry Hill Mortgage announces $10M stock buyback - cherry Hill Mortgage announced that its board has authorized the company to acquire up to $10 million of the company's outstanding common stock. The shares would be acquired from time to time in open market transactions, in block purchases or otherwise over the next 12 months.

16:32 EDT CBIZ acquires Ohio-based employee benefits agency QBA Benefits - CBIZ,announced the acquisition of substantially all the assets of QBA Benefits of Cleveland, Ohio effective August 1. Established in 2018, QBA is an employee benefits agency serving small and mid-sized clients across many industries including service, technology, energy and manufacturing. QBA has eight employees and approximately $2.3 million in revenue. Jerry Grisko, President and CEO of CBIZ, stated, "We're excited to welcome QBA to the CBIZ family. This acquisition brings additional depth and leadership to our employee benefits operations and rounds out the full breadth of CBIZ service offerings in Northeast Ohio. We look forward to working with James and the QBA team to further grow our Ohio market."

16:30 EDT Puma Biotechnology receives Argentina's ANMAT approval for Nerlynx - Puma Biotechnology announced that the Agency of Medicines, Food and Medical Devices, or ANMAT, in Argentina has granted approval of NERLYNX for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.

16:23 EDT Acuity Brands appoints Reece president, Holcom to CFO - Acuity Brands announced that Richard K. Reece was appointed President of the company effective September 1. He was formerly Executive Vice President and Chief Financial Officer of Acuity Brands. MReece assumes responsibility for the commercial operations of the company, including all product creation activities. Also, effective September 1, Karen J. Holcom was promoted to Senior Vice President and CFO of Acuity Brands. She has been with the company for 21 years and has held various positions during her tenure, including controller and interim CFO. Ms. Holcom most recently served as Senior Vice President leading the areas of Finance and Associate Engagement.

16:19 EDT Slack Technologies reports Q2 over $100K paid customers up 37%

16:19 EDT Par Technology to acquire 3M's drive thru communications systems business - ParTech, a wholly owned subsidiary of PAR Technology Corporation (PAR), announced that it has agreed to acquire the assets of 3M's (MMM) Drive Thru Communications Systems business. 3M is a technology leader in drive thru communications for restaurants with a comprehensive offering of wireless headsets for order taking in the drive thru that includes the XT-1 and G5 headset systems. The acquisition is expected to close on September 30.

16:17 EDT Limoneira sells Santa Paula facility for $4.0M - Limoneira announced the sale of its multi-use facility consisting of a retail convenience store, gas station, car wash, and quick serve restaurant located in Santa Paula. The transaction closed on August 30th, 2019 and the Company received approximately $4.0 million in net proceeds. In addition, the Company will record a gain of approximately $0.6 million in its fourth fiscal quarter of 2019.

16:17 EDT Palo Alto Networks intends to acquire Zingbox for $75M - Palo Alto Networks has entered into a definitive agreement to acquire Zingbox, an IoT security company, for a total purchase price of $75M, subject to adjustment, to be paid in cash. The proposed acquisition is expected to close during Palo Alto Networks 1Q20. Zingbox's cloud-based service and advanced AI and machine learning technology for device and threat identification capabilities will accelerate Palo Alto Networks delivery of IoT security through its Next-Generation Firewall and Cortex platforms.

16:08 EDT Golub Capital stockholders approve merger with Golub Capital Investment - Golub Capital obtained stockholder approval of the proposals related to its merger with Golub Capital Investment at a special meeting of the company's stockholders on September 4. Over 96% of GBDC stockholders who voted at the meeting voted in favor of the proposals related to effecting the proposed merger, including the approval of the new investment advisory agreement to be effective upon closing of the merger. At a separate meeting held on September 4, 100% of GCIC stockholders who voted at the meeting voted in favor of the proposed merger. The merger is currently expected to close later in September, subject to satisfaction of customary closing conditions. GCIC stockholders will receive 0.865 shares of GBDC common stock for each share of GCIC common stock.

16:05 EDT Terreno Realty acquires property in Santa Fe Springs, CA for $5.3M - Terreno Realty acquired an industrial property located in Santa Fe Springs, California on August 30, 2019 for a purchase price of approximately $5.3M. The property consists of two industrial buildings containing approximately 30,000 square feet on 1.8 acres. The property is vacant. The estimated stabilized cap rate of the property is 5.2%.

16:05 EDT iRhythm announces collaboration with Alphabet's Verily - iRhythm Technologies (IRTC) announced a collaboration with Verily, an Alphabet (GOOG, GOOGL) company, focused on the development of solutions aimed at improving the screening, diagnosis and management of patients with atrial fibrillation, or AFib. This collaboration brings together iRhythm's expertise in AI based arrhythmia diagnosis and Verily's advanced health data analytics technologies to address the millions of patients living with undiagnosed AFib. Under the terms of the agreement, iRhythm will make an upfront payment to Verily of $5M and potential milestone payments of up to $12.75M upon the achievement of various development and regulatory milestones.

16:03 EDT Mistras acquires New Century Software - Mistras Group announced the acquisition of New Century Software, a leading provider of pipeline integrity management software and services to energy transportation companies. Financial terms of the transaction were not disclosed. The company funded the acquisition with cash on hand.

15:18 EDT SK Telecom, Microsoft announce plans for joint 5G-based cloud gaming in Korea - SK Telecom (SKM) and Microsoft (MSFT) held a press conference to announce their plans to deliver 5G-based cloud gaming in Korea. At the press conference held at SK Telecom headquarters, senior executives of both companies explained in detail their business cooperation and introduced Project xCloud. Project xCloud is Microsoft's game streaming technology that allows gamers to play games on mobile devices while connected to the internet. Supported by SK Telecom's 5G network, which is marked by super-fast speed and ultra-low latency, cloud gaming services can offer a more immersive and seamless experience to gamers...SK Telecom will be an exclusive operating partner of Microsoft's cloud gaming service in Korea. Based on this relationship, SK Telecom is expected to help Microsoft strengthen its position in the mobile gaming market by leveraging its world's leading mobile infrastructure including 5G and LTE; the largest mobile subscriber base in Korea including over 1 million 5G subscribers; cutting-edge ICT such as augmented reality, virtual reality and artificial intelligence; and extensive experience in diverse streaming services. Reference Link

14:51 EDT Transocean sees $580M non-cash charge related to rig retirements - In a regulatory filing last night, Transocean disclosed that the company announced that it intends to retire in an environmentally responsible way, the following three ultra-deepwater floaters: Discoverer Enterprise, Discoverer Spirit, and Discoverer Deep Seas. These rigs are classified as held for sale. As a result of the company's decision on August 27 to authorize retirement of these three rigs and associated equipment, the company expects its third quarter 2019 results to include an estimated non-cash charge of approximately $580M. "As the company continues to evaluate the long-term competitiveness of its fleet, additional rigs may be identified as candidates for retirement," Transocean added in the filing.

14:44 EDT Amazon.com announces second-generation Fire TV Cube - Amazon announced the all-new Fire TV Cube, the second-generation hands-free, Alexa-enabled Fire TV experience, for $119.99. The all-new streaming media player features far-field voice control built directly into the device and is now available for pre-order in the United States, Canada, United Kingdom, Germany, and Japan. "Fire TV Cube was the first hands-free streaming media player powered by Alexa, and since launching last year we have gathered a wealth of feedback from customers about how they use voice in the living room," said Marc Whitten, VP of Amazon Fire TV. "Over the past year, we have continued to expand and advance the Fire TV Cube experience based on this feedback with dozens of new features including Multi-Room Music, Follow-Up Mode, and Alexa Communications. These key learnings carried over and guided the development of the second-generation Fire TV Cube, and we are excited to introduce this new-and-improved experience to customers around the world."

14:17 EDT Hormel Foods announces launch of 'plant-forward' meat alternative brand - During its annual presentation at the Barclays Global Consumer Staples Conference in Boston, Hormel Foods announced the launch of the Happy Little Plants brand, a new plant-forward, protein portfolio created as part of the company's first project under its Cultivated Foods umbrella. Happy Little Plants products launched this week and have distribution in select retail outlets, with further expansion planned in the coming months. "Numerous retailers and foodservice operators have expressed interest based on the exceptional taste, versatility, and simple ingredient statement. Its flagship product is a ground plant-based protein alternative containing 20 grams of non-GMO soy protein, is only 180 calories, with no preservatives, no cholesterol and is gluten-free," Hormel stated in a press release in conjunction with the conference presentation.

13:26 EDT Microsoft acquires cloud migration space provider Movere - Microsoft announced on its website that it acquired Movere, a technology provider in the cloud migration space. "We're committed to providing our customers with a comprehensive experience for migrating existing applications and infrastructure to Azure, which include the right tools, processes, and programs. As part of that ongoing investment, we're excited to welcome the leadership, talent, technology, and deep expertise Movere has built in enabling customers' journey to the cloud over the last 11 years," Microsoft's Jeremy Winter, Partner Director, Azure Management, said in a post. Reference Link

13:01 EDT Schlumberger sees material non-cash impairment charges in Q3 - In a regulatory filing, Schlumberger stated that as a result of the effects of current market valuations as well as various strategic decisions, the company expects that it will, during the third quarter of 2019, record material non-cash impairment charges relating to goodwill, intangible assets and fixed assets. "At the time of the filing of this Current Report on Form 8-K, Schlumberger is unable, in good faith, to make a determination of the amount or range of amounts of such impairment charges," the filing noted.

12:55 EDT Iteris awarded $1M contract by State of Florida - Iteris has received a $1M contract to update the Florida Department of Transportation's Statewide Intelligent Transportation Systems Architecture and seven Regional ITS Architectures to conform to the latest version of the National ITS Architecture, and to reflect the current and planned ITS and advanced technology solutions Florida stakeholders envision. The scope of services also includes annual maintenance updates of the SITSA and RITSAs. Under the five-year agreement, Iteris will review and evaluate each architecture, and define plans for each Florida DOT region to address transportation needs with advanced technology, such as connected and automated vehicles.

12:32 EDT Duke Realty promotes Steven Schnur to COO - Duke Realty Corporation announced that Steven Schnur has been promoted to executive VP and COO. Schnur has been with Duke Realty since 2003. During his tenure, Schnur has held various management positions. In 2017, he was promoted to senior regional Executive VP.

12:08 EDT Altice and Doaln family settle law suit regarding News 12 - A lawsuit filed by the Dolan Family against Altice (ATUS) USA has been settled and the lawsuit dismissed. The parties, prior to trial, have agreed to a settlement that addresses the central issues in the lawsuit, protects News 12 employees and journalistic integrity, and achieves a dismissal of this lawsuit. The notice of dismissal can be found at The Dolan Family filed the lawsuit on September 4, 2018 over concerns about Altice USA's operation of News 12. Altice acquired News 12 as part of its acquisition of Cablevision in 2016.The lawsuit maintained that Altice had not operated News 12 in compliance with the provisions of the 2016 Agreement and Plan of Merger that protected News 12. Altice denied all such allegations. James Lawrence Dolan serves as executive chairman and CEO of The Madison Square Garden Company and executive chairman of MSG Networks(MSG).

12:06 EDT Volkswagen reports August U.S. sales up 9.8% to 35,412 vehicles - Volkswagen of America reports August U.S. sales grew 9.8% compared to the same month of last year to 35,412 vehicles. "We're pleased to close the summer by recording our sixth consecutive month of growth in what has been a challenging year for the industry. The sustained growth of our SUV lineup has us encouraged about our portfolio balance and eager to launch our next SUV in the coming months," said Werner Eichhorn, chief sales and marketing officer, VW, North American Region.

12:00 EDT Comstock Resources rises 15.1% - Comstock Resources is up 15.1%, or 93c to $7.07.

11:39 EDT Alaska Air sees Q3 RASM 13.45c-13.69c vs.13.05c last year - The cost per ASM, excluding fuel and special items, will be between 8.52c and 8.57c, said Alaska Air, versus 8.15c in the year ago quarter.

11:27 EDT Twitter CFO says 'it helps everyone' when engaged with regulators

11:22 EDT JetBlue lowers Q3 RASM growth view (2%)-0% from 0.5%-3.5% - The company said in a filing, "Revenue per available seat mile growth for the third quarter 2019 is expected to range between -2.0 and 0.0 percent year over year, versus our prior range of 0.5 to 3.5 percent. The decrease in our RASM guidance reflects the following trends: Softer bookings to Puerto Rico, equal to a headwind of 1.25 points; Weaker than forecast demand trends across our system, equal to a headwind of approximately 1 point; The preliminary forecasted impact for ongoing Hurricane Dorian, equal to a headwind of approximately 0.75 points. As previously disclosed, our third quarter RASM guidance includes a headwind of 0.75 points, mainly related to challenges in Punta Cana."

11:13 EDT Twitter CFO Segal says views privacy as a basic human right

10:13 EDT Biohaven rallies after update on rimegepant new drug application - Biohaven Pharmaceutical in a presentation at today's Wells Fargo Healthcare Conference included an update on the new drug application filing acceptance and PDUFA date for rimegepant ODT. The FDA informed the company that it has no current plans to hold an Advisory Committee, with filing acceptance and action date planned for in Q1 of 2020, Biohaven said in presentation slides. Further, preliminary evaluation of the application by the FDA did not identify any potential review issues at this time, Biohaven added. The stock is up 7%, or $2.69, to $40.80 in morning trading.

10:00 EDT Navistar rises 7.4% - Navistar is up 7.4%, or $1.62 to $23.48.

09:58 EDT Honda reports August U.S. sales up 17.6% to 173,993 vehicles - American Honda reported that its August U.S. sales were up 17.6% from the prior year to 173,993 vehicles. Honda division sales grew 19.6% to 158,804 vehicles in August, while Acura division sales rose 0.8% to 15,189. "At a time of great change in our industry with the growth of light truck sales and introduction of new technologies, it's gratifying to see American Honda post an all-time best sales month based on great products and maintaining a disciplined approach to the market," said Henio Arcangeli, Jr., senior vice president of Automobile Sales at American Honda Motor.

09:33 EDT Toyota reports August U.S. sales up 11.3% to 248,334 vehicles - Toyota Motor North America, or TMNA, reported August sales of 248,334 vehicles, an increase of 11.3% on a volume basis and up 7.4% on daily selling rate, or DSR, basis versus August 2018. Toyota division achieved a best-ever August, posting sales of 218,403 units, up 12.3% on a volume basis and up 8.3% on a DSR basis. Lexus division posted August sales of 29,931 vehicles, up 4.6% on a volume basis and up 0.8% on a DSR basis.

09:23 EDT Terreno Realty acquires property in Oakland, California, for $23.8M - Terreno Realty acquired an industrial property located in Oakland, California for a purchase price of approximately $23.8M. The property consists of one industrial distribution building containing approximately 93,000 square feet on 4.7 acres adjacent to the eastern terminus of the San Francisco-Oakland Bay Bridge and the Port of Oakland Seaport. The property provides 19 dock-high and six grade-level loading positions, parking for 28 cars and is vacant. The estimated stabilized cap rate of the property is 4.8%.

09:19 EDT LiqTech acquires BS Plastics for $1.4M - LiqTech announced the closing of its recently announced agreement to acquire BS Plastics A/S, a specialized plastic manufacturer based in Denmark. The acquisition allows LiqTech to in-source certain components of its proprietary ceramic silicon carbide water filtration systems for closed loop marine scrubber applications, which the company expects will result in enhanced profitability through improvement to its go forward gross margins. Total upfront consideration paid by LiqTech for BS Plastics was approximately $1.4M, with an additional $900,000 possible through earnouts over the next 3 years. LiqTech funded the acquisition from cash on hand. Based on expected improvement to gross profits from the acquisition as well as contributions from BS Plastics A/S other operations, LiqTech expects a return on investment in approximately one year.

09:16 EDT Vonage announces partnership with transcosmos research and development - Vonage announced a partnership with transcosmos research and development, an R&D and services provider based in Japan. By leveraging Nexmo, the Vonage API platform, transcosmos aims to provide businesses with the digital transformation tools necessary to boost operations productivity, reduce costs and maximize profits. As a Vonage partner, transcosmos research and development will initially provide the Verify API to their global business customers as a way for them to implement a two-step authentication SMS and development support system into their existing framework, achieving reductions in engineering and communication costs, as well as supporting corporate security measures.

09:15 EDT Google's YouTube to pay $170M for alleged violations of child privacy law - Google and its subsidiary YouTube will pay a "record" $170M to settle allegations by the Federal Trade Commission and the New York Attorney General that the YouTube video sharing service illegally collected personal information from children without their parents' consent, the FTC announced. The settlement requires Google and YouTube to pay $136M to the FTC and $34M to New York for allegedly violating the Children's Online Privacy Protection Act, or COPPA, Rule. The complaint notes that the defendants knew that the YouTube platform had numerous child-directed channels. YouTube marketed itself as a top destination for kids in presentations to the makers of popular children's products and brands. For example, Google and YouTube told Mattel (MAT), maker of Barbie and Monster High toys, that "YouTube is today's leader in reaching children age 6-11 against top TV channels" and told Hasbro (HAS), which makes My Little Pony and Play-Doh, that YouTube is the "#1 website regularly visited by kids," the FTC stated. Reference Link

09:13 EDT GeoVax Labs announces publication of Lassa Fever vaccine study results - GeoVax Labs announced publication of its article entitled "A Single Dose of Modified Vaccinia Ankara Expressing Lassa Virus-like Particles Protects Mice from Lethal Intra-cerebral Virus Challenge." The paper appears in the open access journal Pathogens published by MDPI, based in Basel, Switzerland. GeoVax's Lassa fever vaccine is based on the Company's novel Modified Vaccinia Ankara Virus-Like Particle platform, which generates noninfectious VLPs in the individual being vaccinated. VLPs mimic a natural infection, triggering the body to produce a robust and durable immune response with both antibodies and T cells. The paper published in Pathogens reports research showing that a single intramuscular dose of GEO-LM01 provided 100% protection in mice challenged with a lethal dose of ML29 delivered directly into the brain. This is the first report showing that a single dose of a replication-decient MVA vector can confer full protection against a lethal challenge.

09:10 EDT Workiva and BlackLine partner for financial reporting platform integration - Workiva (WK) and BlackLine (BL) announced a platform integration to help joint customers streamline financial close and reporting processes. The data integration is available immediately. The integration aims to enable users to seamlessly connect and transfer data between the two platforms, saving time and reducing risk by improving accuracy and transparency in the record-to-report process.

09:06 EDT Chegg to acquire Thinkful for $80M in cash - Chegg announced that it has entered into a definitive agreement to acquire Thinkful, an online learning platform that offers professional courses directly to students across America. Founded in 2012 by Darrell Silver and Daniel Friedman, Thinkful offers online, outcomes-focused curricula, coupled with live experts, to give learners technology skills such as engineering, data science, data analytics and product design. Chegg expects to acquire Thinkful for approximately $80M in an all-cash transaction. There are potential additional payments of up to $20M, which may be paid in cash or restrictive stock units, at Chegg's sole discretion, subject to performance-based contingencies. The acquisition, which was approved by the boards of directors of Chegg and Thinkful, is expected to close early in Q4, subject to customary closing conditions. Chegg expects, assuming an early Q4 close of the acquisition, the Q4 revenue contribution of Thinkful, after the effect of the fair-value adjustment through purchase accounting to Thinkful's deferred revenue, to be approximately $2M. Thinkful's 2018 net revenue was approximately $14M, an increase of approximately 30% year-over-year. As part of Chegg, the company expects the impact of the acquisition of Thinkful to result in a Q4 adjusted EBITDA loss of approximately $4M, and as the service scales, we expect its adjusted EBITDA to be breakeven in 2020 and to contribute to Chegg's adjusted EBITDA in fiscal years thereafter.

09:06 EDT Assurant partners with Europe's Deposify for cash security deposit platform - Assurant announced a new partnership with Deposify, a European fintech company, that has developed an industry-first technology solution for managing refundable cash security deposits. As a result of this partnership with Deposify, Assurant's property management clients will now have access to a cash security deposit management platform that aims to simplify the financial and operational process and mitigate the risks associated with traditional cash security deposits. Currently available in the Northeast, the service will be rolled out nationally in the coming months.

09:04 EDT Denali Therapeutics doses first patient in Phase 1b study of DNL151 - Denali Therapeutics announced initiation of dosing in a Phase 1b clinical study of LRRK2 inhibitor DNL151 in patients with Parkinson's disease, and the launch of its Engage Parkinson's website. DNL151 is a small molecule inhibitor of leucine-rich repeat kinase 2. LRRK2 is a regulator of lysosomal function, which is impaired in Parkinson's disease and may be restored by LRRK2 inhibition. Inhibition of LRRK2 activity may potentially slow the progression of disease in all patients with Parkinson's disease based on restoration of lysosomal function.

09:03 EDT Fly Intel: Pre-market Movers - HIGHER: OpGen (OPGN), up 78% after combining businesses with Curetis... Ultragenyx (RARE), up 10% after announcing data from the second dose cohort of the ongoing Phase 1/2 study of DTX401, an adeno-associated virus based gene therapy for the treatment of glycogen storage disease type Ia. UP AFTER EARNINGS: Navistar (NAV), up 6%... Michaels (MIK), up 17%. DOWN AFTER EARNINGS: American Eagle (AEO), down 9%... Safe Bulkers (SB), down 9%. ALSO LOWER: Starbucks (SBUX), down 3% after giving a weaker than expected FY20 forecast... Tyson Foods (TSN), down 4% after lowering FY19 guidance... Redwood Trust (RWT), down 3% after its 12.5M share secondary offering priced at $16.08 per share... Superior Industries (SUP), down 10% after suspending its quarterly dividend.

09:00 EDT Proofpoint announces partnership, integration with CrowdStrike - Proofpoint (PFPT) announced a partnership and integration with CrowdStrike (CRWD) to provide organizations worldwide with advanced threat protection across email and endpoints. In the initial integration, Proofpoint's advanced Targeted Attack Protection security intelligence will feed threat intelligence on malicious email attachments into CrowdStrike Falcon to further enhance device security and stop attackers. In the first technology integration, Proofpoint will check potentially malicious attachments with CrowdStrike Falcon Intel and will add unique new hashes to the customer's custom intelligence. An alert will then be created if new related malicious content tries to execute on the device.

08:57 EDT Sunrun to help power Hawaii with rooftop solar, battery network - Sunrun will participate in Hawaiian Electric Company's emerging grid services market by delivering electricity from home solar and batteries to the utility as part of an innovative Grid Services Purchase Agreement with Open Access Technology International. Beginning in 2020 and continuing through at least 2024, Sunrun and OATI will send the energy generated by rooftop solar panels and stored in approximately 1,000 Brightbox home batteries on O'ahu to the electric grid during times of high electricity demand when called upon by Hawaiian Electric. Sunrun's Brightbox battery systems will also send stored solar energy to the grid when there is high energy demand or high-risk of power outages, safeguarding against blackouts and providing reliable, stable power to O'ahu residents.

08:55 EDT Infinity Pharmaceuticals initiates IPI-549, MARIO-3 trials - Infinity Pharmaceuticals (INFI) announced the initiation of two clinical trials for IPI-549, an oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective inhibition of phosphoinositide-3-kinase, or PI3K-gamma. Infinity initiated MARIO-3, a Phase 2 multi-arm study in collaboration with Roche (RHHBY)/Genentech evaluating IPI-549 in combination with Tecentriq and Abraxane in front-line triple negative breast cancer, or TNBC, and in combination with Tecentriq. Following the results from Roche's IMpassion130 study in which Tecentriq and Abraxane received accelerated approval in PDL1+ TNBC patients, MARIO-3 is evaluating the addition of PI-549 to this regimen in both PDL1+ and PDL1- front-line TNBC patients. MARIO-3 also includes a cohort evaluating IPI-549 in combination with Tecentriq and Avastin in front-line PDL1+ and PDL1- renal cell cancer patients. Additionally, Arcus Biosciences initiated a Phase 1/1b study, in collaboration with Infinity, evaluating IPI-549 in a novel combination regimen with AB298, Arcus's dual adenosine receptor antagonist, and Doxil, a chemotherapy, in patients with advanced TNBC.

08:51 EDT Teladoc partners with Johnston Group to offer Teladoc Telemedicine Services - Teladoc Health announces its partnership with Johnston Group, which will see over 30,000 small- to mid-size businesses be the first in Canada to access Teladoc Telemedicine Services. Businesses who are members of the Chambers of Commerce Group Insurance Plan, the number one employee benefits plan for small- to mid-size companies in the country and managed by Johnston Group, will offer their employees in Canada this valuable service, providing 24x7 access to convenient, high-quality medical care regardless of their location across Canada or the U.S. The telemedicine offering expands the portfolio of Teladoc Health virtual care services provided by Johnston Group to Chambers of Commerce Group Insurance Plan members. The two companies also collaborate to offer Best Doctors branded expert medical services, which connect Canadians with world-renowned medical specialists to resolve questions about complex conditions from cancer, heart disease and musculoskeletal issues, to a wide range of other medical issues.

08:49 EDT Starbucks drops 3.5% in pre-market after weaker than expected FY20 forecast

08:46 EDT Weyland Tech's AtozPay, Grab partner for food delivery in Jakarta - Weyland Tech and its mobile fintech partner, AtozPay, have joined forces with Grab to promote the new AtozGo short-distance food delivery service in Jakarta, Indonesia. Launched earlier this week, Grab is supporting a new AtozGo co-marketing campaign, targeting food establishments and mobile users in certain areas of Jakarta. Following a successful roll-out, the campaign is expected to expand to other areas of the city, along with the possibility of a strategic investment by Grab.

08:44 EDT Funko appoints Sarah Kirshbaum Levy to board of directors - Funko (FNKO) announced the appointment of Sarah Kirshbaum Levy to the company's Board of Directors effective September 3, 2019. Levy has served as Viacom (VIA, VIAB) Media Networks' COO since 2016, where she is responsible for overseeing global strategy, finance and operations for the division.

08:41 EDT Aduro Biotech doses first patient in Phase 2 study of ADU-S100 - Aduro Biotech announced that the first patient has been dosed in a Phase 2 clinical trial of ADU-S100, a novel STING pathway activator, in combination with KEYTRUDA, an approved anti-PD-1 antibody, as a first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma.The Phase 2, open-label, multicenter trial, which is part of an ongoing research and development collaboration with Novartis, is designed to evaluate the efficacy and safety of ADU-S100 administered intratumorally in combination with pembrolizumab in the first-line setting. The planned population will consist of 33 adults with PD-L1 positive recurrent or metastatic head and neck cancer.

08:38 EDT B. Riley Financial raises FY19 adjusted EBITDA view to $150M-$170M - B. Riley is raising its full year guidance as a result of continued steady results across its various subsidiaries with better than anticipated performance in its more episodic asset disposition and capital markets businesses.

08:37 EDT Greenlane, Omura announce exclusive partnership for heat-not-burn technology - Omura announced their partnership with Greenlane Holdings for exclusive distribution of Omura vaporizers throughout the United States and Canada. Under this strategic alliance, Greenlane will distribute Omura products in both medical and legal recreational dispensaries as well as independent and chain licensed vape and cannabis retailers. Omura will leverage Greenlane's coast-to-coast network of 11,000-plus retail locations to place the Omura vaporizers in front of its biggest potential consumer base yet. The Omura system is currently available in California, Maryland, and Arizona.

08:36 EDT DelMar Pharmaceuticals relocates headquarters to San Diego - DelMar Pharmaceuticals announced that the company has relocated its headquarters from Vancouver, British Columbia to San Diego, California.

08:35 EDT Simulations Plus announces partnership with clinical-stage biotechnology company - Simulations Plus announced that it has entered into a new funded collaboration with a clinical-stage biotechnology company to develop an intra-articular delivery model in the GastroPlus Additional Dosage Routes Module.

08:34 EDT Tyson Foods sees Kansas plant back in the next couple of months - Says volume impact from Kansas plant has been minimal. Says continues to pay staff even with the plant closed.

08:34 EDT Tyson Foods says 30% of guidance cut is mark-to-market reversal - Comments taken from the Barclays 2019 Global Consumer Staples Conference.

08:32 EDT Global Blood Therapeutics announces new employment inducement grants - Global Blood Therapeutics announced that on September 1, 2019, the compensation committee of GBT's board of directors granted Eric Fink and 8 new employees options to purchase an aggregate of 47,600 shares of the company's common stock with a per share exercise price of $45.98 and restricted stock units for an aggregate of 54,425 shares of the company's common stock. All of the above-described awards were made under the GBT's Amended and Restated 2017 Inducement Equity Plan. Pursuant to the Plan, the exercise price for the 47,600 shares of the Company's common stock was the closing trading price on August 30, 2019, because there was no closing trading price on September 1, 2019.

08:30 EDT KemPharm trading resumes

08:28 EDT Daxor announces 38% rise in BVA-100 cardiology kit sales - Daxor Corporation filed a Form N-CSR disclosing its schedule of portfolio holdings as of June 30, 2019. In reporting its mid-year results, Daxor Corporation has seen important developments in 2019, including a 38% rise in kit sales related to the use of its diagnostic device, the BVA-100 Blood Volume Analyzer, in the area of cardiology, an increase from the prior year's growth of 23% in this category. In addition, the company reported new placements of systems at hospitals utilizing the diagnostic test, as well as increased interest from clinicians and researchers driven by recent positive published data showing substantial benefit from the use of the BVA-100 test in reducing heart failure readmissions and mortality. Overall financial results of total realized and unrealized gain on investments and investment in operating division for the period ending on June 30, 2019 was $498,111. At June 30, 2019, Daxor had net assets of $13,603,768.

08:26 EDT Selecta Biosciences appoints Brad Dahms as CFO - Selecta Biosciences announced the appointment of Brad Dahms as CFO. Prior to joining Selecta Biosciences, Dahms was a SVP in the Healthcare Investment Banking Group at Cantor Fitzgerald & Co.

08:23 EDT Spring Bank Pharmaceuticals announces $20M strategic debt financing agreement - Spring Bank Pharmaceuticals announced that it has entered into a $20M convertible debt financing agreement with Pontifax Medison Finance, a healthcare-dedicated venture debt fund. Under the loan agreement with Pontifax, the loan will mature over 48 months and there are no required payments of principal for 24 months. Pontifax may elect to convert the outstanding loan based on a conversion price of $8.76 per share, which is equal to 2.0 times the 30-day volume weighted average price of Spring Bank's common stock as of the trading day immediately prior to the entry into the loan agreement. In connection with the loan agreement, Spring Bank has agreed to issue to Pontifax warrants to purchase up to an aggregate of 250,000 shares of its common stock at an exercise price of $6.57 per share, which is equal to 1.5 times the 30-day volume weighted average price as of the common stock on the trading day immediately prior to the entry into the loan agreement.

08:22 EDT Starbucks: Long-term double digit EPS growth model 'intact'

08:20 EDT Soliton receives Institutional Review Board approval for fibrotic scar trial - Soliton announced that the company has received approval for the trial protocol from the independent Institutional Review Board for its upcoming proof-of-concept fibrotic scar trial.

08:17 EDT BioXcel Therapeutics receives Orphan Drug Designation for BXCL701 - BioXcel Therapeutics announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation for BXCL701, an investigational orally-available systemic innate immunity activator with dual mechanisms of action, for the treatment of Acute Myeloid Leukemia. BXCL701 is designed to activate innate immune cells, specifically macrophages, by inhibiting the dipeptidyl dipeptidases DPP8 and DPP9, a novel mechanism, and exerts immune stimulatory activity through a pro-inflammatory form of programmed cell death known as pyroptosis. The Company is currently leveraging the pro-inflammatory mechanism of action of BXCL701 for treatment-Emergent Neuroendocrine Prostate cancer and Pancreatic cancer. However, recent preclinical work by Darren C. Johnson, et al, published in the July 2018 Nature Medicine publication, "DPP8/DPP9 inhibitor-induced pyroptosis for treatment of acute myeloid leukemia," has also pointed to AML as a potential indication for BXCL701, since AML cells are of the same lineage as macrophages. Targeting AML represents a novel application of BXCL701's intended mechanism of action of driving programmed cell death. While BXCL701 potentially acts as an activator of the innate immune system in Prostate and Pancreatic cancer, it may act as a direct cytotoxic agent in AML.

08:16 EDT Stryker to acquire Mobius Imaging, Cardan Robotics for $370M upfront - Stryker announced a definitive agreement to acquire Mobius Imaging and GYS Tech in an all cash transaction of approximately $370M upfront and up to $130M of contingent payments associated with development and commercial milestones. The acquisition provides Stryker's Spine division with immediate entry into the intra-operative imaging segment and aligns with Stryker's implant and navigation offerings. Mobius Imaging, founded in 2008, is focused on integrating advanced imaging technologies into medical workflow, which can enhance a clinician's ability to obtain high-quality images. Its Airo TruCT scanner is a best-in-class mobile, real-time, diagnostic-quality CT imaging system. Cardan Robotics, founded in 2015, is working to develop innovative robotics and navigation technology systems for surgical and interventional radiology procedures. The transaction is expected to have an immaterial impact to Stryker's net earnings in 2019. The transaction is subject to customary closing conditions, including expiration of the applicable waiting period under the HSR Act, and is expected to close in the fourth quarter of 2019.

08:13 EDT Foamix announces issuance of U.S. patent covering acne treating methods - Foamix Pharmaceuticals announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 10,398,641 covering a method of treating acne that expires in 2037. U.S. Patent No. 10,398,641 is directed to a method related to the use and topical administration of certain minocycline formulations once daily for at least seven consecutive days to treat acne vulgaris within middle adolescence. This newly issued patent is the latest U.S. patent to issue to Foamix in connection with Foamix's drug development programs for treating acne vulgaris, and expires in September 2037.

08:12 EDT Krystal Biotech initiates Phase 1/2 study of KB105 - Krystal Biotech announced the initiation of the Phase 1/2 study of KB105 in transglutaminase-1 deficient autosomal recessive congenital ichthyosis. The study, termed GEM-3 study, will examine KB105, an HSV-1 based gene therapy engineered to deliver a human TGM1 gene, in patients with ARCI. Up to six subjects are presently planned for the study. Pediatric patients will be enrolled in the study following establishment of safety in adult subjects. This study is an intra-patient comparison of KB105 and placebo-administered target areas. Patients will be evaluated for safety, and target areas will be assessed individually with the Investigator Global Assessment and Visual Index of Ichthyosis Severity scales. Target areas will be imaged and evaluated for safety and efficacy and subjects will be on-trial for approximately 3.5 months.

08:11 EDT Vera Bradley partners wit Warner Bros. to create Harry Potter collection - Vera Bradley has teamed up with Warner Bros. Consumer Products to create an exclusive Vera Bradley + Harry Potter collection which will debut in 2020. Vera Bradley's design team will collaborate with WBCP to create a Vera Bradley + Harry Potter back-to-campus and dorm line featuring bags, accessories, stationery, drinkware, tech products, bath and bedding, which will launch in June 2020. A Vera Bradley + Harry Potter "cozy" capsule featuring a fleece robe, slippers, and a sheared throw blanket will launch in November 2020. The Vera Bradley + Harry Potter products will be available in Vera Bradley Full Line stores, on verabradley.com, and in select retailers beginning in June 2020.

08:10 EDT Moderna appoints Tracey Franklin as Chief Human Resources Officer - Moderna has appointed Tracey Franklin as Chief Human Resources Officer. She will serve on Moderna's Executive Committee. Franklin will join Moderna in October following 15 years at Merck. Most recently, she led Merck's global talent strategy as Vice President, HR Chief Talent and Strategy Officer.

08:07 EDT Blue Apron appoints Julie Betancur as Chief Human Resources Officer - Blue Apron announced the expansion of its leadership team with the appointment of Meredith Deutsch as General Counsel and Corporate Secretary and Julie Betancur as Chief Human Resources Officer. Deutsch and Betancur will report directly to CEO Linda Findley Kozlowski with effective start dates of September 9 and September 10, respectively.

08:06 EDT Trimble acquires 3LOG Systems, terms not disclosed - Trimble announced that it has acquired 3LOG Systems. The acquisition complements Trimble's forestry business software portfolio and expands the Trimble Connected Forest solutions, which offer a complete ecosystem for forest management, traceability and timber processing. Financial terms were not disclosed. Headquartered in Vancouver British Columbia, 3LOG has over 500 installations and provides business software for timber management, wood product and bio-energy companies in North America. By providing enterprise software with integrated mobile field applications, 3LOG solutions manage millions of annual supply chain transactions and connect the forestry business cycle. 3LOG customers include forest owners and timberland managers, pulp and paper mills, softwood mills, hardwood mills, pellet mills, OSB/plywood mills and biomass facilities. Trimble's Connected Forest solutions manage the full raw materials lifecycle of planning, planting, growing, harvesting, transporting and processing finished wood products.

08:03 EDT Ametek acquires Pacific Design Technologies for $125M - Ametek announced that it has acquired Pacific Design Technologies, or PDT. PDT designs and manufactures a complete range of custom-engineered, liquid cooling systems and components used in a broad set of current and next-generation commercial aerospace, defense and space platforms. PDT was privately held and is headquartered in Goleta, California. The company has annual sales of approximately $40M and was acquired for approximately $125M.

07:52 EDT Auxly, Atlantic Cultivation enter agreement with Newfoundland & Labrador - Auxly Cannabis Group, together with its strategic partner, Atlantic Cultivation, announced that it has entered into a comprehensive supply, development and retail agreement with the Province of Newfoundland and Labrador. Under the terms of the agreement, Atlantic will be eligible to apply to operate five new retail locations in the province. Site scouting is currently underway and Atlantic plans to open its first retail store by Q1 2020. Additionally, Auxly will supply to the Province of Newfoundland and Labrador up to 50 kg of dried flower in 2019, up to an additional 1,000 kg in 2020 and an option for up to another 1,000 kg in 2021. Atlantic has agreed to build a 110,000 square foot purpose-built facility in Kenmount Crossing, St. John's, for cultivation, production and processing of high-quality cannabis. Once fully constructed and operational, this facility will create 117 new jobs and will have the capacity to produce approximately 16,000 kg of cannabis annually. Auxly will subscribe for up to 19.9% of the issued and outstanding shares of Atlantic for a total of $2.5 million, which will be used to build out the five retail locations.

07:50 EDT ICL announces collaboration Amazon Web Services - ICL (ICL) announced that it will work closely with Amazon (AMZN) Web Services to accelerate the development of its open digital services platform designed to enhance the capabilities of agronomists and other agriculture professionals, driving farming improvement. The platform will harness in-field, crowdsourced and academic data, as well as data contributed from global partners, to create new capabilities for agro-professionals and the ability to quickly create actionable insights, empowered by data analytics. The development of the new digital services platform for agro-professionals will provide access to data as well as actionable recommendations provided by insights and analytics. The platform is taking advantage of AWS advanced analytics and machine learning tools to unlock these agronomic insights and enable agronomists and other agro-professionals to extend better services to drive growth of crop yields and sustainability. AWS services will extract data from internal ICL sources and external sources by using AWS machine learning solutions. Agro professionals will be able to analyze and query the data using advanced AI analytics tools, including AWS-powered data lakes which can handle the scale, agility, and flexibility required to combine different types of data and analytics approaches. For example, this will allow agro professionals to gain deeper insights, to predict the effect of inputs on crops, while weighting different scenarios of humidity, temperatures and type of soil.

07:48 EDT Virtu Financial appoints Alex Ioffe as CFO succeeding Joseph Molluso - Virtu Financial (VIRT) announced new executive hires and changes to its leadership team. The following leaders join Virtu's executive leadership team: Brett Fairclough has been promoted to COO and Global Head of Business Development at Virtu, where he has worked since 2007. He led Asia Pacific operations from 2014-2019 and was the CCO of Virtu's broker-dealer subsidiaries from 2012-2014. Alex Ioffe will be joining Virtu as its CFO, effective September 30, 2019. Alex will succeed Joseph Molluso, Virtu's current CFO since 2013, who has decided to depart Virtu following a transition period in order to pursue other interests. Alex has almost 20 years of experience within the electronic brokerage industry and over 25 years' experience in financial leadership roles, including most recently as the CFO of the U.S. broker-dealer subsidiary of Interactive Brokers Group (IBKR). Marc Rosenthal joins Virtu's executive team as EVP of Strategy and Corporate Development. Prior to joining Virtu, Marc was a Managing Director in Morgan Stanley's (MS) Equity Division and a senior member of the electronic trading management team. Hyungtaek Kim has been promoted to CAO. Henry has worked at Virtu since 2011, serving in roles of increasing responsibility, including Financial and Operations Principal of Virtu's broker-dealer subsidiaries.

07:41 EDT Aptinyx appoints Rachel Sherman to board of directors - Aptinyx announced the appointment of Rachel Sherman, M.D., M.P.H., former principal deputy commissioner of the U.S. Food and Drug Administration, to the company's Board of Directors, effective immediately. Sherman is currently president of Rachel Sherman Partners LLC, a drug development, regulatory, and policy consulting firm she founded in 2019 following her retirement from the FDA.

07:37 EDT Plug Power opens new Rochester, N.Y. facilities for MEA-production demand - Plug Power announced a major expansion of its presence in New York's Finger Lakes region with the opening of new facilities in Rochester, NY. The expansion arrives less than a year after the grand opening of Plug Power's Rochester-based manufacturing center, and adds to the company's administrative, lab, and warehousing spaces. The move will bring an array of new job opportunities in the fuel cell market to the Greater Rochester area. The new Rochester facilities include engineering and administrative offices, research and development laboratory space, and a warehouse location. Marking the biggest area of growth within the broader expansion, the new labs come equipped with cutting-edge technology and ample resources supporting Plug Power's ongoing efforts to reduce costs, improve durability, and develop new materials for its proprietary membrane electrode assembly technology. Plug Power also expects to expand its personnel with several new hires, recruiting Rochester-based professionals to fill key positions in R&D, chemical engineering, and manufacturing. In addition to creating local job opportunities, Plug Power's Rochester expansion will also serve to facilitate the company's continued collaboration with local schools like the Rochester Institute of Technology and Alfred State College.

07:34 EDT CME Group reports August ADV up 53% to 24.3M contracts - CME Group reached average daily volume, or ADV, of 24.3M contracts during August, up 53% from August 2018 and the second-highest monthly ADV on record. During a month that historically sees lower average daily volumes, August was the company's best August ever. Open interest at the end of August was 139M contracts, up 21% from year-end 2018 and up 14% from August 2018.

07:32 EDT BioCryst reports inducement grants under Nasdaq listing rule - BioCryst Pharmaceuticals announced that the compensation committee of BioCryst's board of directors granted five newly-hired employees options to purchase an aggregate of 112,500 shares of BioCryst common stock on August 30, 2019 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4). The options have an exercise price of $2.99 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant date, in each case subject to the new employee's continued service with the company. Each stock option has a 10 year term and is subject to the terms and conditions of BioCryst's Inducement Equity Incentive Plan and a stock option agreement covering the grant.

07:30 EDT Clearside Biomedical trading resumes

07:27 EDT Anavex announces initiation of EXCELLENCE ANAVEX 2-73-RS-003 clinical study - Anavex Life Sciences announced the approval to initiate the ANAVEX 2-73-RS-003 clinical study of approximately 69 pediatric patients with Rett syndrome, aged 5 to 18, called EXCELLENCE. The EXCELLENCE study is designed as an international study with the first approval by the Australian Human Research Ethics Committee and scheduled to initiate within the next quarters. Safety and efficacy will be investigated in approximately 69 patients over a 12-week treatment period including ANAVEX 2-73-specific precision medicine biomarkers using a convenient once-daily oral liquid ANAVEX 2-73 formulation to treat Rett syndrome. All patients who participate in the study will be eligible to receive ANAVEX 2-73 under a voluntary open label extension protocol. This study is part of the planned Anavex Rett Syndrome Program including ongoing and further studies of ANAVEX 2-73 in wider age range and other geographic regions. Previously, administration of ANAVEX 2-73 resulted in both significant and dose-related improvements in an array of neurologic paradigms in the Mecp2 heterozygous Rett syndrome mouse model at different ages. These paradigms measured different sensory, motor, and autonomic abnormalities of relevance to Rett syndrome, including motor coordination and balance; gait abnormalities; hindlimb clasping, a model of the characteristic hand stereotypies in individuals with Rett syndrome; acoustic startle response; and, in older animals, visual acuity and breathing abnormalities. This data was presented at scientific meetings and is scheduled to be published in a peer-reviewed journal. Anavex is utilizing innovative strategies in trial design in order to effectively and efficiently translate preclinical and clinical findings into an exploration of ANAVEX 2-73 as a potential therapeutic in Rett syndrome.

07:23 EDT GasLog signs ten-year time charter with Sinolam for provision of LNG FSU - GasLog announces that one of its subsidiaries has signed a 10-year time charter with Sinolam LNG Terminal, S.A. for the provision of a liquefied natural gas floating storage unit to a gas-fired power project being developed in Panama. The time charter is expected to be fulfilled through the conversion of the GasLog Singapore, a 155,000 cubic meter, tri-fuel diesel electric LNG carrier built in 2010. The required modifications are such that, as well as being FSU ready, the vessel will still be able to trade as an LNG carrier following the conversion works. The GasLog Singapore's conversion will take place in conjunction with the vessel's scheduled 5-year special survey in the third quarter of 2020, enabling both time and cost synergies with the vessel's regular dry-docking. The charter commences on delivery of the FSU in Panama, which is scheduled for November 2020. The FSU contract is for a fixed period, thereby delivering 100% utilization for the duration of the charter. The FSU will also incur a lower opex than if the vessel was trading as an LNG carrier, with GasLog estimating that the charter will generate approximately $20M of EBITDA per annum over its 10-year life. The FSU will receive, store and send out LNG to a gas-fired power plant currently being developed near Colon, Panama, by Sinolam Smarter Energy LNG Power Company. The power project has signed long-term power purchase agreements with leading Panamanian utility companies as well as a 15-year LNG sale and purchase agreement with Royal Dutch Shell plc.

07:19 EDT Carlyle Group partners with former Domino's Pizza CEO Patrick Doyle - The Carlyle Group (CG) announced a partnership with Patrick Doyle, the former Domino's Pizza (DPZ) President & CEO, to acquire established companies that have the opportunity for value creation and revenue growth through technological transformation. The partnership will initially focus on public and private companies with established brands, proven business models and an enterprise value of up to $10B, as well as family businesses that can benefit from Carlyle's resources and expertise. Carlyle and Mr. Doyle will source opportunities internationally across sectors, and will initially put an emphasis on the consumer and retail sectors in North America and Europe. As an Executive Partner, Mr. Doyle is working with Jay Sammons, Carlyle's Head of Global Consumer, Media & Retail. Together they will leverage the resources of Carlyle's global investment platform and deep expertise across industries. Additionally, Patrick will contribute personal capital to each acquisition. Doyle served as CEO and President of Domino's for almost a decade and joined the company in 1997.

07:18 EDT Fortive announces intention to separate into two independent companies

07:17 EDT Aurora Cannabis sells remaining The Green Organic Dutchman shares for $86.5M - Aurora Cannabis (ACB) announced that it disposed of its remaining 28,833,334 shares, representing 10.5% of the issued and outstanding shares of The Green Organic Dutchman (TGODF), at a price of $3.00 per share for aggregate gross proceeds of $86.5M. The completion of the sale of TGOD shares represents an approximate 50% internal rate of return for the company. As a result of this transaction, Aurora no longer holds any shares of TGOD, however does continue to hold warrants to purchase 16,666,667 shares of TGOD.

07:15 EDT DSP Group, Mimi Hearing Technologies partner to optimize speech intellgibility - Mimi Hearing Technologies announced that it is partnering with DSP Group to improve voice intelligibility on mobile, consumer and enterprise devices by tuning audio output according to a listener's unique hearing ability. Developed and refined through its analysis of 1.5 million individual hearing profiles, Mimi's proprietary sound processing is able to provide a personalized listening experience, allowing users to hear every detail of a conversation. By integrating the technology into DSP Group's portfolio of SoC solutions, powering unified communications phones, mobile phones, wireless hearables and wearables, Mimi will make speech significantly more intelligible for a listener, regardless of their location.

07:13 EDT Orchard Therapeutics announces data from ongoing PoC trial of OTL-203 - Orchard Therapeutics announced data from an ongoing proof-of-concept clinical trial evaluating the safety and efficacy of OTL-203, a gene therapy for the treatment of mucopolysaccharidosis type I developed at the San Raffaele-Telethon Institute for Gene Therapy. The results presented in an oral presentation at the Society for the Study of Inborn Errors of Metabolism symposium include up to 12 months of follow-up for the first patient treated. As of the date of last follow-up, six patients with the severe Hurler subtype of MPS-I have been treated with the cryopreserved formulation of OTL-203 gene therapy. All treated patients were followed for a minimum of two months, with the longest follow-up extending out to 12 months. At the time of treatment, patients ranged in age from 14 months to 35 months. Five out of six patients had previously been treated with enzyme replacement therapy and discontinued ERT treatment three weeks prior to enrollment, consistent with trial protocol. The primary endpoints of the trial are safety, hematological engraftment by day 45 following treatment and preliminary efficacy as measured by IDUA enzyme activity at one-year post-treatment. Treatment with OTL-203 demonstrated: Gene therapy and the selected conditioning regime were well-tolerated. Rapid hematologic reconstitution, with neutrophil and platelet engraftment within three weeks following treatment. Engraftment in the bone marrow and periphery by assessment of the vector copy number. Supranormal IDUA enzyme expression in peripheral blood, with the first patient treated achieving levels 10 times above the normal range and stable over time up to 12 months post gene therapy. Key secondary and exploratory endpoints include normalization of urinary glycosaminoglycans, growth velocity and effects on motor and cognitive function at one- and two-years post-treatment. For the first two treated patients, with 12 months and six months of follow-up, respectively: Rapid metabolic correction of GAG levels in the urine and cerebrospinal fluid was observed, reflecting restoration of IDUA enzyme expression in the periphery and in the central nervous system. For the patient with 12 months of follow-up: Preliminary clinical evaluation showed signs of resumed growth, improved motor skills and a stable cognitive score. The proof-of-concept study is ongoing and expected to enroll eight patients by the first half of 2020, with primary endpoint results reported after one year of follow-up.

07:11 EDT Everbridge appoints Vernon Irvin as Chief Revenue Officer - Everbridge (EVBG) announced that Vernon Irvin has joined the company in the newly created position of Chief Revenue Officer. In this role, Irvin will lead the global sales and field services organization as the company continues to drive growth from its strategic product suites, including Population Alerting and Critical Event Management. The company also announced that Robert Hughes, who has successfully led the overall go-to-market efforts globally for the last two years, will be leaving the company. Irvin was most recently Head of Global Enterprise Business Development at Syniverse, a telecom technology company that spun out of Verizon (VZ).

07:10 EDT Orchard Therapeutics announces results from data analysis of OTL-200 - Orchard Therapeutics announced results from an integrated data analysis of OTL-200, a gene therapy in development for the treatment of metachromatic leukodystrophy at the San Raffaele-Telethon Institute for Gene Therapy. The results, which demonstrate positive clinical effects of OTL-200 in the treatment of MLD and a consistent safety profile, were featured in an oral presentation at the Society for the Study of Inborn Errors of Metabolism symposium in Rotterdam, the Netherlands. As part of this integrated analysis, data from 29 early-onset MLD patients treated with gene therapy were analyzed to assess the efficacy and safety of OTL-200. As of the date of last follow-up, 26 patients are alive and have completed up to 7.5 years of follow-up post-gene therapy. The three patient deaths were deemed unrelated to treatment with OTL-200. Results from patients treated with OTL-200 were compared with those from an age-matched natural history cohort of 31 untreated MLD patients. With the addition of nine patients treated through expanded access programs, the integrated analysis of OTL-200 has demonstrated the following:Consistent with the results from the registrational study, patients treated with OTL-200 in the integrated data analysis demonstrated a reconstitution of arylsulfatase-A enzyme activity in the hematopoietic system and stable engraftment of gene-corrected cells within one-month of receiving treatment. The treatment difference in gross motor function, as measured by gross motor function measurement total score, continued to increase with the addition of more patients. A statistically significant treatment difference in GMFM - above the pre-specified 10 percentage point improvement threshold established in the trial - was observed between OTL-200 treated patients and untreated age-matched participants in the natural history cohort. The treatment difference between late infantile patients and the untreated age-matched natural history cohort was 65.6 percentage points and 71.5 percentage points at two- and three-years of follow-up, respectively. The treatment difference between early juvenile patients and the untreated age-matched natural history cohort was 42 percentage points and 56.7 percentage points at two- and three-years of follow-up, respectively. At an age when patients in the untreated natural history cohort showed severe cognitive impairment, cognitive performance scores were maintained within normal range for most treated patients. Consistent with the results from the registrational study, treatment with OTL-200 was well-tolerated, with no serious adverse events or deaths related to treatment. To date, no cases of malignancy or adverse events indicative of oncogenic transformation have been reported. There was no evidence of abnormal clonal proliferation as assessed by clinical and laboratory examination. As previously reported, two patients in the registrational study who were symptomatic at the time of treatment died due to rapid disease progression unrelated to treatment with gene therapy. One patient in the expanded access cohort died due to ischemic cerebral infarction, also deemed unrelated to OTL-200 treatment. Next Steps for OTL-200 The company intends to complete the necessary development work and prepare a marketing authorization application, or MAA, for submission in Europe in the first half of 2020. Work is also underway to prepare a biologics licensing application, or BLA, for submission in the U.S. approximately one year later. A bridging study is currently underway to assess a cryopreserved formulation of OTL-200 in patients with pre-symptomatic MLD, with data expected by the end of 2019.

07:09 EDT PetroShare files for voluntary reorganization under Chapter 11 - PetroShare Corp. and its wholly-owned subsidiary announced that they have filed voluntary petitions for reorganization under Chapter 11 of the U.S. Bankruptcy Code with the Bankruptcy Court for the District of Colorado. PetroShare intends to pursue efforts to recapitalize the company, which may include the sale of some or all of its assets pursuant to the Bankruptcy Code in a court-supervised process designed to achieve the highest and best price for those assets. The company believes that its cash position is adequate to continue existing operations as a debtor-in-possession and to maintain most staffing and equipment throughout the court-supervised recapitalization and/or sale process. The company has filed a series of motions with the Bankruptcy Court requesting authority to continue normal operations, including authority to continue paying trade creditors, royalty interest holders, and employee wages and salaries in the ordinary course of business. The company will continue to work closely with its suppliers and partners in an effort to ensure that it meets ongoing obligations, and that business continues uninterrupted during the sales process.

07:09 EDT Bristol-Myers, BioMotiv form strategic partnership - BioMotiv and Bristol-Myers announced a new strategic partnership. "The partnership will leverage the strengths of both organizations to develop new and innovative therapies for patients who need them most." Under the terms of the agreement, Bristol-Myers Squibb will become a limited partner of BioMotiv with the option to invest additional funding in selected projects of mutual interest. Under the partnership, BioMotiv and Bristol-Myers Squibb together will form and fund new companies to develop novel therapeutics in disease areas where unmet medical needs remain. Upon the identification of a preclinical candidate molecule, Bristol-Myers Squibb will have the option to acquire the company from BioMotiv under pre-agreed terms.

07:07 EDT Michaels up 31.3% after reporting Q2 results, giving Q3, FY19 guidance

07:06 EDT OpGen, Curetis announce definitive agreement to combine businesses - OpGen and Curetis announced the entry into a definitive agreement to combine the two companies' businesses, subject to approval by both companies' respective shareholders and Curetis' debt financing providers. The transaction is structured as an acquisition by OpGen of Curetis GmbH, a wholly-owned subsidiary of Curetis which owns all of the Curetis Group business. The combination will create a transatlantic, U.S.-headquartered and Nasdaq-listed company with a commercial-stage molecular diagnostics and bioinformatics franchise and a pipeline focusing on infectious diseases and antimicrobial resistance, or AMR. Following the closing, the combined company's U.S. headquarters will be in Gaithersburg, Maryland, while the company's European operations will be run from Holzgerlingen, Germany. Ares Genetics, a subsidiary of Curetis GmbH, will continue its bioinformatics and NGS service laboratory operations in Vienna, Austria. The combined companies will have a broad commercial-stage diagnostics portfolio of CE-IVD-marked and US-FDA cleared products and platforms, as well as a proprietary NGS-based and AI-powered technology and knowledgebase for the rapid molecular prediction of AMR. The initial two main focuses for the company will be rapid diagnostics for lower respiratory infection and urinary tract infection, and bioinformatics and NGS services for AMR prediction by Ares Genetics as well as bioinformatics services based on the Acuitas Lighthouse AMR knowledgebase by OpGen. Key elements of the combined company's strategy include: continuing to gain regulatory clearances and approvals and establish a market position for proprietary molecular diagnostic tests and platforms, capitalize on unique technology platforms, leverage global commercial capabilities and partnerings, pursue development collaborations, and capitalize on the financial leverage and operational and research synergies to improve return on capital and achieve future profitability.The implementation agreement has been approved by both companies' boards. Curetis will seek approval from its shareholders at an extraordinary general meeting and OpGen will seek approval from its stockholders at a special meeting. It is expected that both meetings will be scheduled for Q4. Subject to receipt of shareholder approvals and satisfaction of other closing conditions, as detailed below, the transaction is expected to close by early 2020. Upon completion of the transaction, the combined company's board will be chaired by William Rhodes, currently the chairman of the Curetis supervisory board and will initially consist of four representatives named by Curetis and two by OpGen. Evan Jones, the current chairman, president and CEO of OpGen, will join the combined company's board in a non-executive role. The senior management team of the combined company will consist of Oliver Schacht, currently the CEO of Curetis, as the combined company's CEO, and Timothy Dec, currently the CFO of OpGen, as the CFO of the combined company, and additional representatives from the two companies. Under the terms of the implementation agreement, OpGen proposes to acquire 100% of the shares of Curetis GmbH from Curetis N.V., thereby acquiring all of Curetis GmbH's assets and liabilities, including the Curetis name. Curetis GmbH owns substantially all of the assets, liabilities and contractual obligations of the Curetis Group, including its subsidiaries Curetis USA Inc. and Ares Genetics GmbH. Upon Closing, Curetis GmbH will be a wholly-owned subsidiary of OpGen. At the closing of the transaction, Curetis N.V. will be entitled to receive 2,662,564 new shares of common stock of OpGen, reflecting a valuation of the combined business of roughly $24M. As of September 3, these 2,662,564 new shares would represent approximately 72.5% of the outstanding equity of OpGen and current equity holders of OpGen would hold approximately 27.5% of the equity of OpGen. The respective equity holdings upon closing will be subject to any dilutive issuance of securities by OpGen between the date hereof and the date of Closing. Subject to shareholder approval, Curetis intends to distribute to its shareholders, to the maximum extent permitted by law, the new OpGen shares it will receive at closing in connection with the transaction. The closing is subject to the satisfaction of customary conditions to closing for a transaction of this type, including the absence of a material adverse event for either party, for each of OpGen and Curetis, appropriate approvals by their respective shareholders. For Curetis, consents from certain debt financing providers, the Form S-4 having been declared effective by the U.S. Securities and Exchange Commission, the new shares of OpGen's common stock to be issued in connection with the transaction having been approved for listing on Nasdaq and OpGen having secured additional funding prior to closing.

07:04 EDT Tonix Pharmaceuticals doses participants in Phase 1 study of TNX-601 - Tonix Pharmaceuticals announced that participants were dosed in a Phase 1 study evaluating the safety, tolerability and pharmacokinetics of TNX-601 for the daytime treatment of posttraumatic stress disorder. Topline data from this study investigating new modified release formulations are expected later this year. This open-label Phase 1 formulation study will compare the bioavailability and safety of TNX-601, immediate release and modified release tablets, with a reference product, Les Laboratoires SERVIER Stablon, in 12 healthy male and female volunteers. The study will also evaluate the PK profile of TNX-601 and its metabolite, MC5, using immediate and modified release tablets. Secondary objectives include the evaluation of the safety and tolerability of single doses of TNX-601. The study is being conducted outside of the U.S. using Quotient Sciences' integrated Translational Pharmaceutics platform.

07:00 EDT Party City to hire about 25,000 for Halloween season - Party City announced that it plans to hire approximately 25,000 temporary employees and open up approximately 275 Halloween City pop-up stores in preparation for a busy Halloween season. The company expects to retain about 10% of these employees following the Halloween season.

06:55 EDT Clearside Biomedical trading halted, news pending

06:50 EDT Estee Lauder appoints Deirdre Stanley as general counsel - Estee Lauder (EL) announced that Deirdre Stanley has been appointed executive VP and general counsel, effective October 28. Stanley will jointly report to William Lauder, executive chairman, and Fabrizio Freda, president and CEO. She will join the company's executive leadership team. As executive VP and general counsel, Stanley will be responsible for The Estee Lauder Companies', or ELC, legal organization globally. She will act as a strategic advisor to the organization and to ELC's board of directors on global legal issues and the company's business interests going forward. In this role, she will lead the company's legal strategy, practices and policies globally. Stanley will act as a key partner to ELC's executive leaders and business units across the organization on a wide range of legal matters including corporate strategies, reporting, compliance, risk mitigation, governance and business transactions. She will also lead the company's legal review of potential acquisitions, divestitures and joint ventures. Prior to joining ELC, Stanley served as general counsel for Thomson Reuters (TRI) and its predecessor company for 17 years.

06:49 EDT Tapestry appoints Jide Zeitlin as CEO - Tapestry announced that Jide Zeitlin, the company's chairman of the board, has been appointed CEO. Zeitlin succeeds Victor Luis, who is leaving the company and its board. The company also announced that Susan Kropf, a current member of the Tapestry board, has been named Lead Independent Director. Zeitlin will continue in his role as Chairman. All appointments are effective immediately. At the appropriate time, Zeitlin, with his board colleagues, will lead a search for a future CEO. The company is maintaining its FY20 financial outlook and continues to expect to return approximately $700M to shareholders through its dividend and repurchase programs.

06:34 EDT LHC Group finalizes joint venture agreement with Louisville's Norton Healthcare - LHC Group has finalized a new joint venture agreement with Norton Healthcare in Louisville, Ky., effective Sept. 1. The two organizations will share ownership of Caregivers Health Network, a home health provider serving patients and families in Louisville and the region. Norton Healthcare will purchase a minority interest in the agency, which will be renamed Norton Home Health. Moving forward, the agency will be integrated in accordance with LHC Group's current JV processes and procedures. In Baltimore, LHC Group has finalized the purchase of a home health and home and community based services provider located in Baltimore from VNA of Maryland and Elite Home Care Services - also effective Sept. 1. LHC Group first announced the purchase agreement in July 2019. LHC Group expects annualized revenue from the Baltimore purchase of approximately $35M and that it will not materially affect its 2019 diluted earnings per share.

06:03 EDT DMC Global increases annual cash dividend to 50c per share - DMC Global has increased its annual cash dividend to 50c per share from 8c per share. The dividend will be paid quarterly at a rate of 12.5c per share, with the next payment scheduled for October 15 to shareholders of record as of September 30. The increase more than restores a 16c annual dividend that was reduced in 2015 following the downturn in the oil and gas industry.

05:59 EDT Eldorado says CEO Tom Reeg receives subpoena in SEC trading probe - Tom Reeg, the CEO of Eldorado Resorts (ERI) has been hit with a subpoena in an SEC trading probe, the company said in a regulatory filing. Reeg, whose company is in the process of buying Caesars (CZR) in a $17B merger, received the subpoena in May along with two other Eldorado board members and one Eldorado executive. The filing said the SEC was seeking information about trading in a publicly traded company tied to Eldorado board member James Hawkins, who also received a subpoena. "ERI responded to inquiries by Caesars regarding the matter, and ERI and Caesars agreed to (i) change the composition of the members of the ERI Board at the closing of the Merger in the event that Mr. Reeg was no longer serving as a member of the ERI Board at the closing of the Merger as a result of circumstances specified in the Merger Agreement and (ii) change the composition and number of the members of the ERI Board at the closing of the Merger in the event that Mr. Reeg and Mr. Gary Carano were no longer serving as members of the ERI Board at the closing of the Merger as a result of circumstances specified in the Merger Agreement."

05:50 EDT Celyad doses first patient with CYAD-01 - Celyad announced the successful administration of CYAD-01 produced with the OptimAb manufacturing process to a patient enrolled in cohort 3 of the Phase 1 DEPLETHINK trial.

05:24 EDT Ultragenyx says three DTX401 patients in cohort 2 have shown clinical response - Ultragenyx Pharmaceutical announced data from the second dose cohort of the ongoing Phase 1/2 study of DTX401, an adeno-associated virus based gene therapy for the treatment of glycogen storage disease type Ia. All three patients in cohort 2 have shown a clinical response with improvements in glucose control and other metabolic parameters compared to baseline, the company said in a statement. "Patients in the first, lower dose cohort continue to show longer-term durability in response," it added. The data were presented today at the Society for the Study of Inborn Errors of Metabolism 2019 Annual Symposium in Rotterdam, the Netherlands. Based on these results, Ultragenyx will enroll three additional patients into an expansion of cohort 2 at the same dose to confirm its use in the Phase 3 study, which is expected to begin in 2020. All patients have demonstrated a biological and clinical response, reflected by an increase in time to hypoglycemia compared to baseline during a controlled-fasting challenge, including a sustained response through week 52 for the first two patients enrolled. All patients will continue to be followed to evaluate long-term durability of treatment, says Ultragenyx. As of August 31, there have been no infusion-related adverse events and no treatment-related serious adverse events reported,it noted. All adverse events have been Grade 1 or 2. Four of the six patients in Cohorts 1 and 2 had mild, asymptomatic elevations in alanine aminotransferase and were successfully treated with a reactive tapering course of steroids.