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

19:19 EDT Power Integrations CEO sells 4.7K shares of common stock - In a regulatory filing, Power Integrations disclosed that its CEO Balu Balakrishnan sold 4.7K shares of common stock on April 2nd. The total transaction size was $334K.

19:00 EDT Intel names George Davis as CFO, effective April 3 - Intel (INTC) announced the appointment of George Davis as executive vice president and CFO, effective April 3. Davis will report to Intel CEO Bob Swan and oversee Intel's global finance organization, including finance, accounting and reporting, tax, treasury, internal audit and investor relations. He will also oversee Intel's information technology organization. Davis joins Intel from Qualcomm (QCOM), where he served as executive vice president and CFO since March 2013.

18:53 EDT Fly Intel: After Hours Movers - UP AFTER EARNINGS: Dave & Busters (PLAY) up 6.4%. ALSO HIGHER: Blue Apron (APRN) up 14.6% after naming new CEO... Urban Outfitters (URBN) up 1.9% after getting upgraded to Buy at DA Davidson... Advanced Micro Devices (AMD) up 1.3% after being initiated at Buy at Nomura... GrubHub (GRUB) up 0.6% after being initiated at Buy at BTIG. DOWN AFTER EARNINGS: Usana (USNA) down 14.3% after below-consensus Q1 pre-announcement and cutting FY19 outlook... GameStop (GME) down 8.5%. ALSO LOWER: Gritstone Oncology (GRTS) down 2.8% after its data on indentifying MHC class 2 antigens at AACR... Qualcomm (QCOM) down 0.9% after CFO resignation. Movers as of 18:30ET.

18:33 EDT Midland States to acquire HomeStar Financial Group in a stock deal - Midland States and HomeStar Financial announced that they have entered into a definitive agreement whereby Midland will acquire 100% of the common stock of HomeStar, and its wholly owned subsidiary HomeStar Bank and Financial Services , in exchange for 405K of Midland common stock. HomeStar Bank is a full-service community bank headquartered in Manteno, Illinois, with approximately $375M of assets, $223M in loans and $333M in deposits as of December 31, 2018. Serving its communities for over 70 years, HomeStar Bank has 5 locations in northern Illinois and has the #1 deposit market share in the Kankakee, IL metropolitan statistical area . For the quarter ended December 31, 2018, HomeStar had a cost of deposits of 0.20%, an average loan yield of 5.13%, and a net interest margin of 3.88%.

18:00 EDT FTC warns jewelry marketers over deceitful diamond ads - The Federal Trade Commission staff sent eight letters to jewelry marketers warning them that some of their online advertisements of jewelry made with simulated or laboratory-created diamonds may deceive consumers, in violation of the FTC Act. The letters note that in July 2018, the FTC issued updated Guides for the Jewelry, Precious Metals, and Pewter Industries that provide marketers with information on how to make non-deceptive representations about jewelry and related products, including mined, lab-created, and simulated diamonds. Failure to follow the Guides, the staff warns, may result in enforcement actions if the FTC determines the companies engaged in unfair or deceptive acts or practices. Such actions could result in civil penalties if the company engaged in practices knowing that the Commission has already deemed them deceptive in earlier litigation. In the letters, the staff expresses concerns that some of the companies' advertising fails to conform to the current version of the Guides, and may therefore deceive consumers. Specifically, the staff points out examples where the advertising might imply that a simulated diamond is a lab-created or mined diamond, or that a lab-created diamond is a mined diamond, or where required disclosures about the source of the diamonds are not proximate to the individual product descriptions. To help educate the companies, the letters caution them not to use the name of any precious stone, including diamonds, to describe a simulated or lab-created stone, unless the name is immediately proceeded by a clear and conspicuous disclosure that the product is not a mined stone. The staff also encourages companies selling simulated diamonds to avoid describing their products in a way that may falsely imply that they have the same optical, physical, and chemical properties of mined diamonds. The letters also note that similar non-deceptive disclosures are required when advertising jewelry containing precious stones other than diamonds, including emeralds and rubies, as well as pearls. Publicly traded companies in the jewelry space include Signet (SIG), Tiffany (TIF), DGSE Companies (DGSE), Kingold Jewelry (KGJI), and Birks Group (BGI).

17:39 EDT Cannell Capital reports 6.75% stake in Build-A-Bear - Cannell identified Build-A-Bear as an entity satisfying each investment vehicle's investment criteria and intends to hold the shares as a long-term investment.

17:18 EDT Cavco Industries names William Boor as CEO, succeeding Daniel Urness - Cavco Industries announced that its Board of Directors has appointed William Boor as CEO, effective April 15. Boor will succeed Daniel Urness, who served as President and Acting CEO since November 2018. Urness will resume his former role of Executive Vice President, CFO and Treasurer, also effective April 15. Boor assumes his new role as CEO with over 10 years of experience with Cavco, most recently serving as non-executive Chairman of the Board for the company. Boor will remain a member of the company's Board of Directors. The Board has named independent Board member Steven Bunger to serve as the company's new non-executive Chair of the Board. Richard Kerley has been appointed Chairman of the Audit Committee. Both of these Board appointments are effective immediately.

17:17 EDT Cavco Industries names William Boor CEO - Cavco Industries announced that its board of directors has appointed William Boor as Chief Executive Officer, effective April 15, 2019. Boor will succeed Daniel Urness, who served as President and Acting Chief Executive Officer since November 2018. Urness will resume his former role of Executive Vice President, Chief Financial Officer and Treasurer, also effective April 15, 2019. Boor assumes his new role as CEO with over 10 years of experience with Cavco, most recently serving as non-executive Chairman of the Board for the company.

16:57 EDT Yuma Energy names Anthony Schnur as interim CEO - Yuma Energy announced that on April 2, 2019, it filed its annual report on form 10-K for FY18 with the SEC. On March 28, 2019, Mr. Anthony C. Schnur was appointed Interim Chief Executive Officer of the company, replacing Mr. Sam L. Banks. Mr. Schnur has also served as Chief Restructuring Officer of the company since March 1, 2019. The company continues to reduce corporate overhead and operating costs, and is focused on higher margin operations and cash conservation following a comprehensive review of its business and assets. Yuma Energy recently entered into an agreement to sell the California assets for $2.1M to provide near term liquidity. Similar asset sales are under review and may follow but are undetermined at this time.

16:45 EDT Cooper Companies VP Agostino Ricupati sells over $710K in company shares - Cooper Companies VP Agostino Ricupati disclosed in a regulatory filing that he had sold 2,400 shares of company stock on March 29 at an average price of $296.13 per share, for a total transaction value of $710,722.

16:35 EDT Natus Medical announces accretive sale of Medix business - Natus Medical announced that it has signed a definitive agreement to sell its wholly-owned subsidiary, Medix Medical Devices, SRL, in an employee led buyout. As part of this divestiture, Natus will sell the Medix line of products, including incubators, warmers and other Medix products. Under its new ownership, Medix will continue to distribute Medix products as well as the previously distributed line of Natus products and other third party products in Argentina and Venezuela. Medix will also provide ongoing customer service, sales and customer support, and warranty and repair services for the Medix line of products."This divestiture is an important step toward refocusing our business on our core products and investing in the markets we expect to grow in the future," said Jonathan A. Kennedy, President and CEO of Natus. "We remain committed to the markets we serve, and will ensure a smooth and orderly transition for our customers and employees." The Medix business generated $7.6M of revenue in 2018 and was expected to contribute approximately $6M to 2019 revenue. The divestiture of Medix is expected to be accretive to Natus' operating income margin going forward. We anticipate incurring $3M to $4M of transaction and disposal expenses as part of the divestiture. We will update full year revenue guidance with the impact of this divestiture in our Q1 2019 earnings release.

16:34 EDT FDA approves Cellectis' Investigational New Drug for Phase 1 trial in MM - Cellectis announced that the FDA has approved the company's Investigational New Drug, or IND application, to initiate a Phase 1 clinical trial for UCARTCS1, in patients with multiple myeloma, or MM. The IND for UCARTCS1 was filed on December 28, 2018 and approved by the FDA within a month, on January 25, 2019. UCARTCS1 is based on a tailored manufacturing process developed by Cellectis, which removes both the CS1 antigen and TCR from the T-cell surface using TALEN gene editing technology, before adding the CS1 CAR construct. This approach has both clinical and operational benefits: the UCART is designed to have a lymphodepleting effect, and the CAR T-cell cross reaction is suppressed, allowing for successful manufacturing. UCARTCS1 is the first allogeneic CAR-T therapy for MM to enter clinical development.

16:31 EDT TechnipFMC awarded contract for Neptune Energy Duva and Gjoa P1 projects - TechnipFMC has been awarded a "substantial" integrated Engineering, Procurement, Construction and Installation contract from Neptune Energy for the Duva and Gjoa P1 projects, located in the Norwegian sector of the North Sea at a water depth of 375 meters. For TechnipFMC, a "substantial" contract ranges between $250M and $500M. The contract covers the delivery and installation of subsea equipment including umbilicals, rigid flowlines and subsea production system.

16:24 EDT Blue Apron names Linda Kozlowski CEO, affirms Q1, FY19 outlook - Blue Apron (APRN) announced that its board has appointed Linda Findley Kozlowski as President, Chief Executive Officer, and a member of the board, effective as of April 8, 2019. Kozlowski brings a record of success at innovative, consumer-focused companies, having most recently served as Chief Operating Officer of Etsy (ETSY). Brad Dickerson, who joined Blue Apron as Chief Financial Officer in February 2016 and was appointed as President, CEO and a member of the Board of Directors in November 2017, has decided to resign in order to pursue new opportunities. Following Kozlowski's appointment, he will serve as an advisor to the company for a period of time to assist with the transition. In addition, Ilia Papas, Blue Apron's co-founder and Chief Technology Officer, will be departing the company to pursue new opportunities. His last day with Blue Apron will be May 3, 2019. The company has a transition plan in place. Based on its current view of the business, Blue Apron also reaffirms its prior guidance of a significant improvement in net loss and achieving profitability on an adjusted EBITDA basis for the first quarter of 2019 and for full year 2019.

16:18 EDT Cousins Properties signs lease with FleetCor - Cousins Properties (CUZ) announced that it has signed a new long-term lease with FLEETCOR Technologies (FLT) for 46,000 square feet at Terminus 100, a 660,000 square-foot office tower located in the Buckhead submarket of Atlanta. FLEETCOR will occupy the space most recently occupied by Bain & Company.

16:16 EDT Model N names Chris Lyon as Chief Revenue Officer - Model N (MODN) announced that Chris Lyon has joined as Chief Revenue Officer. Mr. Lyon brings more than 25 years of enterprise sales, sales operations and strategy experience at leading software companies such as Workday and PeopleSoft. Prior to that, he served as Vice President of North America for the healthcare vertical at Workday (WDAY).

16:14 EDT GameStop reports Q4 comparable store sales increase of 1.4% - Total global sales from continuing operations decreased 7.6% to $3.1B, resulting in a consolidated comparable store sales increase of 1.4% -- 3.4% increase in the U.S. and 2.9% decrease internationally. The primary contributors to the difference between the increase in comparable store sales and the decrease in total company sales was the shift in the company's fiscal calendar for the 53rd week in FY17 and the timing of the Call of Duty launch.

16:13 EDT GameStop announces cost savings initiative - As a result of the strategic and financial alternatives review conducted in FY18, GameStop announced that it is "embarking on a cost savings and profit improvement initiative designed to strengthen the organization for the future and support long-term improved financial performance and profitability. These initiatives include supply chain efficiencies, operational improvements, expense savings and pricing and promotion optimization. Based on initial estimates, which are preliminary and could change as the program is implemented throughout the year, the company is working to achieve annualized operating profit improvements of approximately $100M. Given the timing of the program, the company expects minimal impact on FY19 results."

16:09 EDT Kura Oncology presents new findings on tipifarnib at AACR - Kura Oncology reported new findings regarding the mechanism of action of the company's lead drug candidate tipifarnib and its potential clinical applications. These findings are being presented at the American Association for Cancer Research, or AACR. Tipifarnib is a potent and selective farnesyl transferase inhibitor currently in a registration-directed clinical trial in patients with head and neck squamous cell carcinoma, or HNSCC, that carry mutations in HRAS, an exclusively farnesylated oncogene. Tipifarnib has also been shown to downregulate production of the chemokine CXCL12 in tumor models and cancer patients. New findings suggest that gene expression of the exclusively farnesylated proteins RHOE, or RND3, and PRICKLE2 is associated with CXCL12 expression in bone marrow stroma, which may provide a mechanistic rationale for why the CXCL12 pathway is a therapeutic target of tipifarnib and other farnesyl transferase inhibitors. In addition, an analysis of a subset of patients from a previously conducted Phase 2 trial of tipifarnib in patients with relapsed and refractory lymphomas identified pre-treatment tumor CXCL12 expression as a potential biomarker of clinical benefit in patients with diffuse large B-cell lymphoma, or DLBCL, and mycosis fungoides, the most common form of cutaneous T-cell lymphoma, or CTCL. This observation is consistent with similar findings from Kura in other indications such as peripheral T-cell lymphoma, acute myeloid leukemia and pancreatic cancer. CXCL12 and its receptors, CXCR4 and CXCR7, have been implicated in cancer progression and poor prognosis across a large spectrum of solid tumor and hematologic indications.

16:06 EDT Alexander & Baldwin names Brett Brown CFO, succeeding Diana Laing - Alexander & Baldwin has named Brett Brown as executive vice president and CFO, effective May 8. Brown will succeed Diana Laing, who will continue as interim CFO through May 7. Brown comes to A&B from PREP Property Group, where he currently serves as CFO and treasurer.

16:06 EDT SI Financial's stockholders approve merger with Berkshire Hills Bancorp - SI Financial Group (SIFI), the holding company for Savings Institute Bank and Trust Company, announced that the stockholders of the company approved the previously announced merger of the company with and into Berkshire Hills Bancorp at a meeting of the company's stockholders held on April 2. The stockholders of the company also approved the non-binding proposal with respect to the merger-related compensation payable to the executive officers of the company. Subject to the receipt of the required regulatory approvals and the satisfaction of customary closing conditions, the parties expect to close the merger in the second quarter of 2019.

16:04 EDT Syros Pharmaceuticals' SY-1365 predictive of response in HGOC models - Syros Pharmaceuticals presented new preclinical data across its franchise of selective cyclin-dependent kinase 7 inhibitors at the AACR Annual Meeting in Atlanta. New data on SY-1365, a first-in-class selective CDK7 inhibitor currently in a Phase 1 clinical trial, suggest that RB pathway alterations are predictive of response in preclinical models of high-grade ovarian cancer, or HGOC, and support the ongoing clinical investigation of SY-1365 in patient populations enriched for RB pathway alterations. New preclinical data on SY-5609, a selective oral CDK7 inhibitor, demonstrate broad anti-tumor activity in preclinical models of triple-negative breast cancer and ovarian cancer. Eric R. Olson, Syros' Chief Scientific Officer, said: "The data highlight our ability to discover highly selective small molecule inhibitors of CDK7, a target that has been historically difficult to drug selectively, as well as to identify potential patient selection strategies to enable targeted and efficient clinical development. We remain focused on executing on the ongoing Phase 1 trial evaluating SY-1365 in select ovarian and breast cancer patient populations that we believe are most likely to respond. Meanwhile, we also continue to advance SY-5609, our highly selective and potent oral CDK7 inhibitor, toward a Phase 1 study. Together, we believe SY-1365 and SY-5609 could make for a powerful CDK7 franchise with the potential to provide a profound benefit for patients." Overall, Syros believes these results support the ongoing development of SY-1365 in patient populations, including HGSOC and CDK4/6-inhibitor resistant hormone receptor-positive breast cancer, that are enriched for RB pathway alterations, as well as the evaluation of these alterations as potential biomarkers of response to SY-1365. Syros is currently conducting a Phase 1 clinical trial assessing the safety and efficacy of SY-1365 as a single agent and in combination with standard-of-care therapies in multiple ovarian and breast cancer patient populations.

15:01 EDT BriaCell announces clinical trial collaboration agreement with Incyte - BriaCell Therapeutics announced a clinical trial collaboration and supply agreement with Incyte. Under the terms of the agreement, BriaCell will evaluate combinations of novel therapeutics for the treatment of patients with advanced breast cancer. Under the agreement, Incyte will provide compounds from its development portfolio, including INCMGA0012, an anti-PD-1 monoclonal antibody, and epacadostat, an IDO1 inhibitor, for use in combination studies with BriaCell's lead candidate, Bria-IMT, in advanced breast cancer patients.

14:05 EDT Senate committee to probe FAA inspectors of Boeing 737 Max 8 - U.S. Senator Roger Wicker, chairman of the Committee on Commerce, Science, and Transportation today launched an investigation of "any potential connection between inadequate training and certification of Aviation Safety Inspectors who may have participated in the evaluation of the Boeing 737 Max 8 aircraft." The investigation comes in light of recent 737 crashes and information obtained from whistleblowers, Wicker said in a press release. Reference Link

13:35 EDT Volkswagen reports March U.S. sales up 14% to 37,092 units - Volkswagen of America reports March U.S. sales rose 14% to 37,092 units. Reference Link

13:17 EDT Walmart teams with Google on voice-enabled grocery shopping - Tom Ward, SVP, Digital Operations, Walmart (WMT) U.S. said in an earlier blog posting: "Beginning this month, customers can say, "Hey Google (GOOG), talk to Walmart" and the Google Assistant will add items directly to their Walmart Grocery cart. Best of all, customers can be extra confident that we can quickly and accurately identify the items they are asking for with the help of information from their prior purchases with us. The more you use it, the better we'll get...It's cross-platform, which means customers can use any device utilizing Google Assistant, and allows for items to go directly to a customer's shopping cart, making this capability one of a kind. We're kicking off the work with Google, adding others to the mix as time goes on.Over the next few weeks, the service will roll to more and more customers." Reference Link

13:10 EDT Jounce Therapeutics reports new clinical data on vopratelimab - Jounce Therapeutics reported new clinical data on vopratelimab at the American Association for Cancer Research Annual Meeting. "The Jounce poster presentations show that patients in the ICONIC trial with emergence of ICOS hi CD4 T cells have improved progression free survival and overall survival compared to patients with ICOS lo CD4 T cells. Data related to important immune characteristics of ICOS hi CD4 T cells were also presented," said the company. Three groups of Iconic relapsed refractory solid tumor patients were compared in the new analysis: 18 patients who have demonstrated ICOS hi CD4 T cells in the blood, 32 patients who have demonstrated ICOS lo CD4 T cells, and a group of patients enrolled in parts A through D which includes an additional 151 patients that were not tested for ICOS status due to lack of samples, according to Jounce. It added, "The emergence and persistence of the ICOS hi CD4 T cell biomarker in the peripheral blood is associated with improved PFS and OS: All benefit in the study, measured by tumor reductions, PFS and OS, was in the ICOS hi CD4 T cell group; PFS: median 6.2 months for patients with ICOS hi CD4 T cells vs 2 months for both patients with only ICOS lo CD4 T cells and All Patients; OS: median not yet reached for patients with ICOS hi CD4 T cells vs 9 months for patients with only ICOS lo CD4 T cells and 9.1 months for All Patients." Richard Murray, CEO of Jounce Therapeutics, said, "We are encouraged by the improved PFS and OS data associated with the emergence of the ICOS hi CD4 T cell biomarker and are convinced that meaningful advancements in immuno-oncology will require the type of science-based translational understandings that the Jounce team and platform have enabled to advance vopratelimab thus far. We have established our translational technology base for the purpose of creating a preclinical and, more importantly, clinical scientific understanding of the mechanism of action of new immunotherapies and the characteristics of responding versus non-responding patients to focus the next steps of clinical development for vopratelimab and our pipeline."

13:07 EDT Scholar Rock presents additional preclinical data on SRK-181-mIgG1 - Scholar Rock announced additional data on the mechanism of action of a highly specific inhibitor of TGFbeta1 activation in syngeneic mouse tumor models that emulate clinically-observed primary resistance to checkpoint blockade therapy. Detailed preclinical results are being presented at the American Association for Cancer Research, or AACR, annual meeting. The preclinical data demonstrate that treatment with SRK-181-mIgG1, a highly specific inhibitor of TGFbeta1 activation, in combination with an anti-PD1 immunotherapy, can drive tumor regression or control, resulting in significant survival benefit compared to anti-PD1 monotherapy, the company said. In addition, newly presented immune response data show that combination treatment leads to infiltration and expansion of CD8+ T cells and a reduction of immunosuppressive myeloid cells, suggesting TGFbeta1's multiple contributions to primary resistance to CBT. "These new preclinical results reinforce our belief that a highly specific inhibitor of TGFbeta1 activation can enable the immune response to overcome a key mechanism of primary resistance to checkpoint blockade therapy, even in tumors that express other TGFbeta isoforms, and could meaningfully expand the number of patients who could benefit from checkpoint blockade therapies. With the recently announced nomination of SRK-181 as the first product candidate in our cancer immunotherapy program, we are eagerly working towards initiating a Phase 1 trial in patients with solid tumors in mid-2020," said Nagesh Mahanthappa, President and CEO of Scholar Rock.

13:05 EDT Lockheed, Intel collaborate to launch hardened security solution - Lockheed Martin (LMT) has collaborated with Intel (INTC) to deliver a hardened security solution based on new 2nd Generation Intel Xeon Scalable processors to help protect against cyber threats while providing more consistent service performance. "Lockheed Martin and Intel have created an innovative solution to help protect against complex cyber threats," said Glenn Kuller, vice president of Advanced Programs at Lockheed Martin Missiles and Fire Control. "This collaboration combines decades of Lockheed Martin's global security expertise and Intel's computing platform experience."

12:31 EDT Carvana advances over 4% after announcing expansion of California market - Carvana announced earlier that it was launching in three new California markets, offering as-soon-as-next-day vehicle delivery to Stockton, Modesto and Vallejo area residents."Offering as-soon-as-next-day vehicle delivery in our first market in California in 2017 was a significant milestone in our coast-to-coast growth," said Ernie Garcia, founder and CEO of Carvana. "To now bring the new way to buy a car to a total of 10 cities in the state of California is an accomplishment we're proud of, and we're looking forward to Stockton, Modesto and Vallejo residents embracing the easy, tech-forward car buying and selling we offer." Shares of Carvana are currently up $2.43 per share of over 4% to $61.37 per share in midday trading.

12:11 EDT Fathom Events, Meteor 17 form strategic partnership for content development - Fathom Events and Meteor 17, founded by music and media producer Spencer Proffer, have entered into a long-term "First Look" and production agreement for projects to premiere on the Fathom Events platform, with Proffer serving as the event and added-value content producer. This content agreement will initially focus on the music vertical as well as culturally relevant topics and initiatives, both of which are foundational to Fathom and Meteor 17. For these events, Proffer will serve as event producer for involved parties, including superstar musical talent, political leaders and pop culture icons and their concerts, programs, interviews and speeches. Additionally, he will produce original, added-value segments, which will screen alongside the core exhibitions. Fathom Events is owned by AMC Entertainment (AMC); Cinemark Holdings (CNK); and Regal Cinemas, a subsidiary of the Cineworld Group.

12:05 EDT Sempra Energy unit SoCalGas to replace 20% of natural gas supply with RNG - Southern California Gas SoCalGas released a broad, inclusive and integrated plan to help achieve California's ambitious environmental goals in a paper titled California's Clean Energy Future: Imagine the Possibilities. The plan embraces an all-of-the-above approach to fight climate change, keeps energy affordability as a key focus, calls for developing long-term renewable energy storage using existing infrastructure, and can aid in promoting rapid consumer adoption. The new strategy comes one month after SoCalGas announced its vision to be the cleanest natural gas utility in North America, delivering affordable and increasingly renewable energy to its customers. As part of that vision, SoCalGas committed to replace 20% of its traditional natural gas supply with renewable natural gas RNG, by 2030. ,"Achieving California's ambitious climate goals will require business leaders, non-governmental organizations, and policymakers to work together to re-imagine how California's energy infrastructure can operate as one, integrated system that maximizes emissions reductions and minimizes waste," said Bret Lane, SoCalGas chief executive officer. "Implementing a balanced approach that promotes advanced energy technologies will allow California to keep energy affordable and reliable and preserve consumer choice."

12:00 EDT PIMCO High Income Fund falls -10.5% - PIMCO High Income Fund is down -10.5%, or -95c to $8.09.

12:00 EDT Delta Air Lines rises 6.8% - Delta Air Lines is up 6.8%, or $3.55 to $55.73.

12:00 EDT AmeriGas rises 11.5% - AmeriGas is up 11.5%, or $3.57 to $34.70.

11:40 EDT FDA to hold hearing on potential regulatory pathways for cannabis products - The FDA issued a statement from outgoing Commissioner Scott Gottlieb on new steps to advance the agency's continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products, in which he stated in part: "In recent years, we've seen a growing interest in the development of therapies and other FDA-regulated consumer products derived from cannabis and its components, including cannabidiol, or CBD...We also recognize that stakeholders are looking to the FDA for clarity on how our authorities apply to such products, what pathways are available to market such products lawfully under these authorities, and how the FDA is carrying out its responsibility to protect public health and safety with respect to such products." The FDA is announcing a number of new steps and actions to advance its consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under its existing authorities, Gottlieb said. These new steps include: A public hearing on May 31, as well as a broader opportunity for written public comment, for stakeholders to share their experiences and challenges with these products, including information and views related to product safety; The formation of a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health; Updates to its webpage with answers to frequently asked questions on this topic to help members of the public understand how the FDA's requirements apply to these products; and the issuance of multiple warning letters to companies marketing CBD products with "egregious and unfounded claims that are aimed at vulnerable populations." Publicly traded companies in the cannabis space include Aphria (APHA), Aurora Cannabis (ACB), CV Sciences (CVSI), CannTrust Holdings (CNTTF), Canopy Growth (CGC), Cronos Group (CRON), General Cannabis (CANN), India Globalization Capital (IGC), MediPharm Labs (MLCPF) and Tilray (TLRY).

11:10 EDT TJX announces 18% increase in common dividend to 23c per share - The TJX Companies announced that its Board of Directors has raised the amount of its quarterly dividend by 18% from the last dividend paid. The Board declared a regular quarterly dividend in the amount of 23c per share, payable June 6 to shareholders of record on May 16. Ernie Herrman, CEO nd President of The TJX Companies, stated, "I am pleased to report that our Board of Directors has approved an 18% increase in our quarterly dividend. This marks our 23rd consecutive year of dividend increases. Over this period, the Company's dividend has grown at a compound annual rate of 22%. In addition, we plan to continue our significant share buyback program, with approximately $1.75B-$2.25B of repurchases planned for Fiscal 2020. TJX continues to generate tremendous amounts of cash and deliver strong financial returns. These actions underscore our confidence in our ability to continue delivering profitable sales and strong cash flow, which enables us to simultaneously reinvest in the growth of the business and return value to our shareholders."

10:34 EDT General Motors reports Q1 U.S. sales down 7.0% to 665,840 vehicles - General Motors announced that it delivered 665,840 vehicles in the first quarter of 2019, down 7.0% compared to the first quarter of last year. GM sales in the first quarter of 2019 were down 7% year-over-year compared to "a very strong first quarter of 2018," the company stated. Q1 average transaction prices for GM's all-new, light-duty pickups were $8,040 higher compared to their outgoing models in the first quarter of 2018, with the GMC Sierra leading the segment, according to GM, quoting J.D. Power PIN estimates. Elaine Buckberg, GM chief economist, said, "Consumer sentiment continued to recover in March and the other key drivers of auto sales like employment, wage growth and household balance sheets are healthy. The Fed paused in raising interest rates, which eases a headwind facing auto sales. Overall, the U.S. economy is in solid shape, which bodes well for the industry outlook."

10:05 EDT Overstock's tZERO appoints Elliot Grossman as CEO of retail broker-dealer - tZERO, a portfolio company of Medici Ventures, the blockchain subsidiary of Overstock.com, announced that Elliot Grossman has been appointed CEO of its upcoming broker-dealer affiliate. Grossman, who was most recently the managing director of equity trading at institutional brokerage firm Dinosaur Financial Group, will oversee the establishment and management of the anticipated retail brokerage services affiliate, the company said.

10:00 EDT PIMCO High Income Fund falls -10.0% - PIMCO High Income Fund is down -10.0%, or -91c to $8.13.

10:00 EDT Medley Management falls -12.0% - Medley Management is down -12.0%, or -42c to $3.08.

10:00 EDT NIO Inc. rises 6.3% - NIO Inc. is up 6.3%, or 33c to $5.54.

09:48 EDT Fiat Chrysler reports March U.S. auto sales down 7.3% to 200,307 vehicles - Fiat Chrysler said its March U.S. auto sales declined 7.3% year-over-year to 216,063 vehicles. "The industry had a tough first quarter but with spring finally starting to show its face and continued strong economic indicators -- such as a boost in housing sales, lower lending rates and a strong labor market -- we are confident that new vehicle sales demand will strengthen going forward," U.S Head of Sales Reid Bigland said. "Meanwhile, our Ram brand sales and average transaction prices continue to be strong and our much-anticipated, game-changing Jeep Gladiator pickup is on track for its in-market debut this month." Fiat Chrysler reported March sales for the Ram brand rose 15% to 51,822 vehicles. The Jeep brand dropped 11% to 87,328 vehicles while the Fiat brand dropped 45% and Chrysler brand dropped 38%.

09:47 EDT PIMCO High Income Fund falls -9.6% - PIMCO High Income Fund is down -9.6%, or -87c to $8.17.

09:47 EDT Tata Motors rises 5.6% - Tata Motors is up 5.6%, or 78c to $14.63.

09:47 EDT AmeriGas rises 10.4% - AmeriGas is up 10.4%, or $3.24 to $34.37.

09:44 EDT Toyota's March U.S. sales dropped 3.5%, Bloomberg reports

09:29 EDT DHX Media to sell building on Bartley Drive Toronto for $12.0M - DHX Media has entered into an Agreement of Purchase and Sale to sell a building it owns on Bartley Drive, Toronto. The sale is part of the Company's ongoing strategic shift to focus and streamline its operations. Under the terms of the agreement, DHX Media has agreed to sell the facility for total consideration of $12.0M. The transaction is expected to close on or about June 6 and is subject to customary closing conditions. Proceeds from the transaction will be used to pay down debt.

09:23 EDT TOP Ships announces new time charter with Shell Tankers for M/T Eco Palm Desert - TOP Ships (TOPS) announced that it has entered into a time charter agreement with Shell Tankers (RDS) for its 50,000 dwt product/chemical tanker M/T Eco Palm Desert until September 2020. The time charter with Shell consists of a fixed amount per day plus a 50% profit share for earned rates over the fixed amount and replaces a pre-existing charter.

09:20 EDT Delta Air Lines up 4.5% to $54.55 after raising Q1 guidance

09:16 EDT Instructure signs agreement to acquire MasteryConnect - Instructure announced it has signed an agreement to acquire MasteryConnect, a longtime partner and innovator in the design and delivery of formative and interim assessment that supports personalized and mastery-based learning. Through this acquisition, Instructure will accelerate the shift occurring at the state level as they replace high-stakes, end-of-year testing with innovative assessment models. The acquisition is expected to close within the next seven days and is subject to satisfaction of customary closing conditions, including approval by MasteryConnect stockholders.

09:13 EDT Walgreens Boots Alliance will invest over $1B over next 3 years

09:11 EDT IMAC to acquire ISDI Holdings - IMAC announced the signing of a merger agreement to acquire ISDI Holdings, or ISDI, a practice management group that manages three clinics in the Chicago area. The three managed clinics had consolidated net revenue of $5M and net income of $800,000 for the 12 months ended December 31, 2018. Under the terms of the merger agreement, IMAC will issue 1,002,306 shares of common stock at closing, which is expected to occur in Q2 following the satisfaction of certain conditions included in the merger agreement. Pursuant to the merger agreement, ISDI will merge with and into IMAC's wholly-owned subsidiary IMAC Management of Illinois. IMAC expects to identify approximately $50,000 of annual cost synergies in connection with the merger.

09:10 EDT Delta Air Lines sees Q1 total unit revneues up approximately 2% - Says remains on target to return ~ $2.5B for full year.

09:09 EDT Delta Air Lines sees Q1 TRASM, adjusted up ~ 2% - Sees Q1 system capacity up 5% y/y. Sees Q1 CASM-Ex flat to up 0.5% y/y. Sees Q1 average fuel price per gallon $2.03-$2.08. Guidance from investor update in 8k filing.

09:05 EDT Fly Intel: Pre-market Movers - HIGHER: ADMA Biologics (ADMA), up 54% after announcing FDA approval for Asceniv intravenous immune globulin... Sangamo (SGMO), up 49% after announcing, with Pfizer (PFE), interim data from the Phase 1/2 Alta study evaluating investigational SB-525 gene therapy for severe hemophilia A... Aveo (AVEO), up 11% after reporting results from an investigator-sponsored Phase 1b expansion cohort of ficlatuzumab in combination with cytarabine in patients with relapsed and refractory acute myeloid leukemia... CommScope (COMM), up 5% after Credit Suisse analyst Sami Badri upgraded the stock to Outperform from Neutral ahead of the Arris (ARRS) acquisition deal closure... Emcore (EMKR), up 7% after B. Riley FBR analyst David Kang upgraded shares to Buy from Neutral. DOWN AFTER EARNINGS: Walgreens Boots Alliance (WBA), down 9%... AngioDynamics (ANGO), down 7%. ALSO LOWER: Apyx Medical (APYX), down 39%, after the company said it will voluntarily withdraw its 510(k) application for the use of its Renuvion product in dermal resurfacing procedures... UGI Corporation (UGI), down 7% after announcing that they have entered into a merger agreement under which UGI will fully consolidate its ownership of AmeriGas (APU) by acquiring the 69.2M publicly held common units it does not already own... Senior Housing (SNH), down 22% after modifying its existing business arrangements with Five Star Senior Living (FVE) and increasing its current 8.3% ownership in the company to approximately 34%.

09:04 EDT Gulf Resources receives PRC approval to open two bromine factories - Gulf Resources announced it received approval from the PRC local government to open its bromine factories subdivision of Factory No. 1 and #7. These facilities have passed all approvals both in the factories themselves and in the mines and crude salt ponds. The company expects to begin operations of its bromine factories subdivision of Factory No. 1 and #7 within this week or next week. Factory #7 is expected to have the highest production capacity among the factories. Factories #1 and #9 have passed all approvals for the work inside the factories. However, the local government has asked for some additional work to be done outside the factories on the bromine wells and aqueducts. The company expects that the work on factories #1 and #9 will be completed soon. Since these factories have passed rectification inside the factories, the company expects to receive full approval in the next one to two months and to commence production in these factories by the end of Q2. The remaining three factories including #2, #8 and #10 have both internal and external issues. However, the company believes these issues can be resolved within the second. The company expects to have all seven factories and related facilities to be in operation by end of year.

09:02 EDT Walgreens Boots Alliance: business bodel 'well positioned' for long-term growth - Walgreens Boots Alliance management says the business model is well positioned to deliver sustainable long-term adjusted EPS growth. Sees rising contribution from partnerships beyond 2022. Says investments in short to mid-term to drive EPS growth.

09:00 EDT American Express, Delta Air Lines sign 11-year renewal extending SkyMiles cards - American Express (AXP) and Delta Air Lines (DAL) have signed an 11-year renewal extending their exclusive Delta SkyMiles Credit Cards from American Express portfolio through the end of 2029. The long-term agreement will leverage shared strengths, while continuing existing features, including: ongoing investment in industry-leading benefits for Delta SkyMiles Credit Cards from American Express, complimentary access to the network of Delta Sky Clubs around the world for Delta Reserve Card Members and Platinum Card Members from American Express, Delta participation in the Membership Rewards program from American Express, allowing those points to transfer into the SkyMiles Program and Delta as an American Express Card-accepting merchant. As the two companies work together, Delta expects its benefit from the relationship to double to nearly $7B annually by 2023, up from $3.4B in 2018, strengthening Delta's increasingly diversified revenue stream.

08:47 EDT Walgreens Boots Alliance continues to de-emphasize tobacco - The company experienced a 125 basis points impact to retail sales due to its de-emphasis of tobacco.

08:42 EDT Clovis announces interim results from Rubraca Phase 2 study - Clovis Oncology announced multiple presentations at the 2019 American Association for Cancer Research Annual Meeting, including presentation of interim results from an investigator-initiated Phase 2 trial of Rubraca in platinum-sensitive patients with advanced pancreatic cancer. Early data from the study are encouraging and suggest that first-line maintenance therapy with Rubraca following induction with platinum-based chemotherapy provides disease control with no new safety signals among patients with a pathogenic mutation in BRCA1, BRCA2 or PALB2. Between 5 to 8 percent of patients with pancreatic cancer have a pathogenic mutation in BRCA1, BRCA2 or PALB2. The University of Pennsylvania-based study is an ongoing, single-arm phase 2 trial investigating monotherapy Rubraca in the first-line maintenance setting. The study will enroll a total of 42 patients with advanced pancreatic cancer and a pathogenic germline or somatic BRCA1, BRCA2 or PALB2 mutation, whose cancer has not progressed following at least four months of platinum-based chemotherapy. The primary endpoint of the trial is progression-free survival and responses are determined using RECIST v1.1. At the interim analysis, the median PFS in 19 evaluable patients was 278 days or 9.1 months from the start of Rubraca therapy. At a median potential follow-up of 244 days, median overall survival had not been reached. According to the authors, of the 19 patients evaluated at the last data cutoff, one patient had a complete response and six more patients had partial responses, including responses in patients with germline BRCA2 mutations, germline PALB2 mutations and somatic BRCA2 mutation. Eight of the 19 patients were on Rubraca for greater than6 months and two patients remained on treatment for greater than1 year. The disease control rate at 8 weeks follow-up was 89.5 percent. Overall, Rubraca treatment in this study was well tolerated without dose-limiting toxicities. The toxicities considered possibly related to treatment occurring in greater than1 patient included nausea, dysgeusia, fatigue, ALT increase, diarrhea, vomiting, AST increase and anemia. There were no grade greater than or equal to3 events reported for these treatment related toxicities. A poster titled "Comprehensive genomic profiling of greater than1000 plasma and tumor tissue samples from metastatic castration-resistant prostate cancer patients gives insight into targeted treatment strategies" was presented Sunday. This study highlighted the cancer genomics of tissue and plasma samples screened for the TRITON2 study evaluating Rubraca in mCRPC. Patients with deleterious alterations in DNA-damage repair genes were identified using both tissue and plasma-based assays, and there was a high concordance between the alterations detected with both assay types. A poster titled "Enhancement of anti-PD-1 antitumor efficacy in syngeneic preclinical models by the angiogenesis inhibitor lucitanib" was presented Monday and shows that lucitanib combined with an anti-PD-1 agent enhances the anti-tumor activity of either single agent in multiple syngeneic animal models. The mechanism of action is thought to be through both antiangiogenic effects and immunomodulatory effects on dendritic cells and T cells. These data provide preclinical support for a planned study of lucitanib in combination with the anti-PD-1 inhibitor nivolumab in gynecologic cancers, expected to initiate in the first half of 2019. A poster titled "Intracranial evaluation of the in vivo pharmacokinetics, brain distribution, and efficacy of rucaparib in BRCA-mutant, triple-negative breast cancer" will be presented later today. These data describe in vitro and in vivo pharmacokinetic studies which suggest limited brain penetration of multiple PARP inhibitors in mice with an intact blood-brain barrier. However, antitumor activity was observed with Rubraca in a BRCA1-mutant intracranial triple-negative breast cancer animal model. The poster also includes a case report of a patient with breast cancer associated with a germline BRCA2 mutation and CNS involvement who had complete resolution of neurological symptoms following Rubraca treatment. The data presented in the poster provide insights into the complex pharmacokinetic and biological parameters associated with CNS activity of PARP inhibitors. Lastly, two Trials in Progress posters describing the trial designs of the Clovis-sponsored ATHENA and ATLAS studies are also being presented today. ATHENA is a Phase 3 study of Rubraca and nivolumab following front-line platinum-based chemotherapy in ovarian cancer. ATLAS is a Phase 2 study of Rubraca in patients with locally advanced or metastatic urothelial carcinoma. Both studies are currently enrolling patients.

08:40 EDT SG Blocks announces exclusive partnership with BHCV - SG Blocks signed a master service agreement with Blockchain Holdings Capital Ventures, or BHCV, as the firm's sole partner in designing and fabricating its single and multi-container data centers. These low-cost, decentralized innovative data centers will offer secure and affordable solutions for BHCV's customers-including built-in disaster recovery options.

08:38 EDT Walgreens Boots Alliance says conditions in UK remain challenging - The company is taking immediate actions to improve operational performance.

08:37 EDT NewLink Genetics presents NLG207 results at AACR - NewLink Genetics announced results from a Phase 2 study of NLG207, a nanoparticle formulation of the topoisomerase 1 inhibitor camptothecin, conducted in conjunction with The GOG Foundation, in patients with refractory ovarian cancer. The data were presented in a poster session at the American Association for Cancer Research, or AACR. In the study, NLG207 was administered in combination with paclitaxel to patients with recurrent ovarian, fallopian tube, or peritoneal cancer in a Phase 1b/2, single-arm, open label expansion study. Thirty patients were enrolled and all received at least one cycle of treatment. The primary objective of the study was overall response rate per RECIST 1.1. Secondary objectives included evaluation of progression-free survival,or PFS, PFS at 6 months and duration of response in patients with recurrent platinum resistant cancer and safety. The combination therapy of NLG207 plus weekly paclitaxel was well tolerated in heavily pretreated patients with most adverse events consistent with those observed for paclitaxel as a single agent. Prior single agent activity observed in both preclinical and clinical studies, along with Phase 2 results in combination with paclitaxel reported here, support further investigation of NLG207 as a single agent and in combination treatment regimens for patients with recurrent ovarian, fallopian tube or primary peritoneal cancers, particularly those which are platinum resistant.

08:25 EDT Foamix settles Hatch-Waxman litigation with Perrigo - Foamix (FOMX) announced that, together with LEO Pharma, it has settled the Hatch-Waxman litigation with Perrigo (PRGO), relating to Finacea Foam. Terms of the settlement are not disclosed. As required by law, the parties will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.

08:21 EDT Ocular Therapeutix announces FDA acceptance of supplemental NDA for DEXTENZA - Ocular Therapeutix announced the U.S. Food and Drug Administration has accepted for filing the supplemental New Drug Application for DEXTENZA to include the treatment of ocular inflammation following ophthalmic surgery in its label. The notice of acceptance confirms the FDA has completed its initial review of the filing and has determined that the sNDA is sufficiently complete to permit formal review. The FDA has set a Prescription Drug User Fee Act target action date of November 10, 2019 for its review of the sNDA. DEXTENZA is the first FDA-approved intracanalicular insert delivering dexamethasone to treat post-surgical ocular pain for up to 30 days with a single administration. DEXTENZA received FDA approval in November 2018 for the treatment of ocular pain following ophthalmic surgery. DEXTENZA is a resorbable, preservative-free ophthalmic insert that is placed in the lower lacrimal punctum and into the canaliculus of the eye. The sNDA application to include inflammation is supported by the two Phase 3 clinical trials used to obtain the pain approval and safety and efficacy data from a third prospective, multicenter, randomized, controlled Phase 3 clinical trial of DEXTENZA in cataract surgery patients that demonstrated statistical significance compared to the vehicle control for the endpoints of absence of ocular pain and absence of inflammation. The ocular safety profile was similar to that demonstrated in the two prior Phase 3 clinical trials.

08:16 EDT Cyclerion Therapeutics begins trading, announces plan for five sGC programs - Cyclerion Therapeutics announced its launch as an independent, publicly traded clinical-stage biopharmaceutical company harnessing the power of soluble guanylate cyclase, or sGC, pharmacology to discover, develop and commercialize treatments for serious and orphan diseases. Cyclerion will trade on the Nasdaq Global Market. Cyclerion initially plans to advance five differentiated sGC stimulator programs that are designed to target tissues of greatest relevance to the diseases they are intended to treat. These programs include olinciguat in Phase 2 development for sickle cell disease, praliciguat in Phase 2 trials for heart failure with preserved ejection fraction and for diabetic nephropathy, IW-6463 in Phase 1 development for serious and orphan central nervous system diseases and two late-stage discovery programs targeting serious liver and lung diseases, respectively. Topline data read-outs for each of the clinical programs are expected by the end of the year.

08:13 EDT Amira Nature Foods regains compliance with NYSE listing requirements - Amira Nature Foods announced that it has received notification from the New York Stock Exchange that the company has regained compliance with the NYSE's continued listing standard regarding the price of Amira's ordinary shares. The company had received notification regarding the price deficiency on November 16, 2018. The NYSE requires that the average closing price of a listed company's shares be no less than $1.00 per share over a consecutive 30 trading day period and close above $1.00 per share on the last trading day of the month to regain compliance. The company has been notified by the NYSE that is has cured the price condition and regained compliance with all NYSE continued listing requirements as of March 29.

08:11 EDT Fat Brands announces three-unit development deal for co-branded concept in Texas - FAT Brands announces the development of three co-branded Fatburger and Buffalo's Express concepts in the Dallas-Fort Worth metro area. In partnership with Ever Suite Group, the co-branded restaurants will expand in Texas over the next three years.

08:11 EDT ResTORbio initiates Phase 1b/2a trial of RTB101 - ResTORbio announced the initiation of a Phase 1b/2a trial of RTB101, its orally administered, small molecule, potent inhibitor of target of rapamycin complex 1 product candidate, alone or in combination with sirolimus, in Parkinson's disease.

08:08 EDT Ribbon Communications extends partnership with Neustar - Ribbon Communications announced that it is extending its partnership with Neustar, a leading global information services provider and the exclusive host of the ATIS Robocalling Testbed, to deliver a comprehensive solution designed to combat robocalling and call spoofing. Earlier this year, Ribbon announced that its software and appliance-based session border controllers and its policy and routing, or PSX, solutions had successfully completed interoperability testing to support a major industry effort, STIR-SHAKEN, which is designed to help service providers protect consumers against unwanted robocalls and caller ID spoofing. Secure Telephone Identity Revisited (STIR) standards and the Signature-based Handling of Asserted information using toKENs framework were developed by the IETF and ATIS/SIP Forum NNI Task Force, respectively. Ribbon and Neustar have teamed up to provide the leading integrated solution to implement STIR-SHAKEN and mitigate spoofed calls and robocalls.

08:05 EDT Bojangles appoints Jackie Woodward as Chief Marketing Officer - Bojangles announced that Jackie Woodward has joined the company as its new Chief Marketing Officer, reporting directly to Jose Armario, CEO. Woodward will work alongside the brand's respected long-time marketing chief Randy Poindexter over the next several months to ensure a seamless transition. The company recently announced Poindexter's retirement after 28 years as the iconic brand's top marketing executive. Woodward comes to Bojangles' with more than 30 years of marketing experience in domestic and global markets.

08:04 EDT Vertex appoints Charles Wagner as EVP, CFO - Vertex Pharmaceuticals announced the appointment of Charles Wagner as EVP and CFO, effective April 10, 2019. Mr. Wagner will report directly to Vertex chairman, president and CEO Jeffrey Leiden and oversee the finance, internal audit, investor relations, and global security and facilities functions. Wagner joins Vertex from Ortho Clinical Diagnostics, where he served as CFO and EVP, Finance.

08:02 EDT Perrigo settles its Hatch-Waxman litigation - Perrigo Company announced that it has settled its Hatch-Waxman litigation relating to its tentatively-approved generic version of Finacea Foam, or azelaic acid, 15% pursued by LEO Pharma A/S, LEO Pharma and Foamix Pharmaceuticals. Terms of the settlement are confidential.

07:51 EDT Pacific Biosciences announces retrospective study on PacBio sequencing published - Pacific Biosciences announced that a retrospective study conducted by scientists at the Anthony Nolan Research Institute in the UK demonstrated that ultra-high-resolution HLA typing performed with PacBio sequencing identified stronger matches associated with improved survival rates among patients who received hematopoietic cell transplants. The study was published in the Journal of Biology of Blood and Marrow Transplantation. HLA typing involves analysis of the genes found in the human leukocyte antigen region of the human genome. For stem cell transplants, HLA typing is used to find the best donor/recipient match for the strongest chance of a positive outcome for transplant patients. The HLA genes are polymorphic and complex, making them very difficult to resolve fully with conventional technologies. They are also known to be important in immune-related diseases and drug hypersensitivity. The Anthony Nolan Research Institute has implemented single molecule, real-time, or SMRT, sequencing from PacBio to fully phase and characterize HLA genes with accuracy. In this retrospective study, the scientists aimed to determine whether high-resolution HLA typing enabled by SMRT sequencing would have made a difference for previously matched donors and recipients. They analyzed 891 donor/recipient pairs, all of which had originally been considered a perfect match. SMRT sequencing revealed that 29.1% of those matches were not actually perfect and identified previously undetected variation in nearly a quarter of the pairs. The patients whose 12/12 matches were confirmed by SMRT sequencing had a significantly improved 5-year overall survival, or OS, of 54.8% compared to 30.1% OS for those who were thought to be 12/12 matched using standard technology. Perfectly matched patients were also less likely to die of other transplant-related complications in the 12 months post-transplant, and significantly less likely to develop acute graft-versus-host disease. The study highlights the importance of sequencing through previously uncharacterized regions of the traditional HLA genes, showing that polymorphisms in these regions affect patient overall survival.

07:42 EDT Flexion announces Zilretta independent review data published - Flexion announced an independent evaluation of clinical data for Zilretta, conducted by Adis Drug Review, was published in the journal Drugs.The evidence-based evaluation concluded that Zilretta provided effective pain relief, while being generally well-tolerated as demonstrated in clinical studies and it expands the treatment options for osteoarthritis, or OA, knee pain. Adis Drug Review provides an independent analysis of data on new or established treatments, across all therapeutic areas, to determine clinical potential. Their assessment of Zilretta included data from six clinical trials conducted over the past seven years, which evaluated 1,347 patients, 613 of whom were treated with Zilretta. Treatment with a single injection of Zilretta provided significant pain relief in patients with OA knee pain relative to placebo with respect to average daily pain, or ADP, scoring in clinical trials and provided a similar level of pain relief to that of a single injection of triamcinolone acetonide crystalline suspension, or TAcs. In the Phase 3 trial, patients who received Zilretta reported improvements in pain, stiffness and physical function compared with TAcs and placebo in pre-specified exploratory endpoints, which utilized the OA-specific Western Ontario and McMaster Universities Arthritis Index. Furthermore, they also reported improvements compared with TAcs and placebo on the Knee Injury and OA Outcome Score Quality of Life assessment. Zilretta had a similar tolerability profile to those seen with TAcs and placebo. Zilretta was generally well-tolerated with most adverse events, or AEs, being of mild to moderate severity and no radiographic evidence of rapidly progressing OA was observed over the 24-week study period in the Phase 3 trial. Patients with type 2 diabetes receiving Zilretta in the Phase 2 trial experienced a significantly smaller change in blood glucose elevation compared with those receiving TAcs and a negligible impact on their glycemic control. Results from the single-arm Phase 3b trial showed that the tolerability of repeat administration of Zilretta was consistent with that seen in the single administration Phase 3 trial. An analysis of radiographs taken at baseline and Week 52 showed no evidence of deleterious effects on cartilage or other aspects of joint structure with the repeat administration. Data suggest that a repeat administration of Zilretta may be similarly efficacious to an initial injection without further increasing the risk for AEs. The most frequent AE in patients who received two injections of Zilretta was arthralgia in any joint, including two treatment-related arthralgia cases after the first injection and no treatment-related cases following the second injection. Additional studies with Zilretta, including longer-term evaluations, use in other joints, and head-to-head studies with TAcs, may be valuable in establishing relative efficacy and tolerability. A randomized, double-blind, placebo-controlled Phase 3 trial evaluating the safety and efficacy of Zilretta in patients with hip OA is currently enrolling. The study is expected to complete in 2020.

07:35 EDT Rapid7 acquires NetFort - Rapid7 announced it has acquired NetFort. Rapid7 plans to bring NetFort's network monitoring, visibility and analytics capabilities into its insight cloud to help customers advance. Rapid7's Insight cloud delivers a combination of network visibility, security analytics, orchestration and automation used by organizations to manage risk, detect and stop attacks and orchestrate security operations across their modern networks. The insight cloud processes billions of events and monitors millions of assets daily, collecting and analyzing data from the endpoint to the cloud. Bringing NetFort's network monitoring, traffic visibility and analytics capabilities into the insight cloud will allow Rapid7 to consolidate more data and analytics into a single platform for security and IT professionals. The acquisition of NetFort is not expected to have a material financial impact to Rapid7's annualized recurring revenue growth, revenue, non-GAAP operating income and non-GAAP net income per share for FY19.

07:30 EDT Synthesis Energy Systems trading resumes

07:20 EDT Calithera Biosciences presents preclinical CB-708 data at AACR - Calithera Biosciences announced new preclinical data for the company's CD73 inhibitor CB-708. The data will be presented at the American Association for Cancer Research, or AACR. CB-708 is a selective, oral inhibitor of CD73, an enzyme that synthesizes the immunosuppressive agent adenosine and is over-expressed in multiple tumor types. By blocking adenosine production in the tumor, CB-708 is designed to enhance T-cell activation leading to anti-tumor activity. Calithera plans to initiate clinical development of the compound in the second half of 2019. The preclinical data being presented demonstrates that CB-708 is a potent and selective inhibitor of CD73 that has immune-mediated, single agent activity in syngeneic mouse tumor models. In addition, in pre-clinical studies CB-708 is well-tolerated and shows enhanced anti-tumor activity when combined with either an anti-PD-L1 immunotherapy or with chemotherapeutic agents such as oxaliplatin or doxorubicin.

07:17 EDT Nova Measuring selected by leading global Memory manufacturer - Nova announced that a leading global Memory manufacturer recently selected its latest X-Ray materials metrology solution for high volume manufacturing in its advanced fabrication lines. This win adds a new name to our growing materials metrology customer base and solidifies Nova's unique leadership position for materials metrology in the Memory segment. The company expects to recognize initial revenues from this win in the Q1 and forecasts additional orders throughout 2019 as the customer expands the solution to additional applications and sites.

07:16 EDT ADMA Biologics reports FDA approves Asceniv intravenous immune globulin - ADMA Biologics announced that the U.S. Food and Drug Administration has approved Asceniv Immune Globulin Intravenous, Human - slra 10% Liquid, formerly referred to as RI-002. Asceniv is an Intravenous Immune Globulin drug product for the treatment of Primary Humoral Immunodeficiency Disease, or "PIDD," in adults and adolescents. The company anticipates having the product available for commercial launch during the second half of 2019. "We are excited about this significant achievement in receiving FDA approval for Asceniv a novel, patented IVIG product that we feel is a necessary addition to existing available therapies for patients who suffer from PI. We hope availability of Asceniv will help ameliorate a portion of the current shortages facing U.S. IVIG supply," stated Adam Grossman, President and CEO of ADMA Biologics. "With the receipt of Asceniv's FDA approval, ADMA, at its sole option, can elect to access up to an additional $27.5M of available funding from Perceptive Advisors under ADMA's existing credit facility. This option remains available to the company through June 2020, and such funds could be used to support the launch of Asceniv, procure plasma raw material inventory, and begin construction on potential new plasma centers, as well as for general corporate activities," concluded Grossman.

07:12 EDT Bausch + Lomb announces U.S. Launch of LOTEMAX SM - Bausch + Lomb announced it has begun distributing LOTEMAX SM 0.38% to U.S. pharmaceutical distributors. The company received final approval by the U.S. FDA on February 22. LOTEMAX SM is a new gel drop formulation of loteprednol etabonate, which was designed with novel SubMicron technology for efficient penetration to key ocular tissues at a low preservative level and a pH close to human tears. It is indicated for the treatment of postoperative inflammation and pain following ocular surgery.

07:12 EDT iRadimed receives 510 clearance from the FDA for features on vital signs monitor - iRadimed announced that it received FDA 510 clearance for neonatal use of the pulse oximetry and capnography monitoring features of its 3880 magnetic resonance imaging, or MRI, compatible patient vital signs monitoring system. The company designed the 3880 MRI-compatible patient vital signs monitoring system using non-magnetic components and other features enabling the safe and accurate monitoring of a patient's vital signs during various MRI procedures.

07:10 EDT Amneal Pharmaceuticals appoints Pradeep Bhadauria as Chief Scientific Officer - Amneal Pharmaceuticals announced that the company has appointed Pradeep Bhadauria as Chief Scientific Officer, effective immediately. He will succeed current Chief Scientific Officer Dr. Shankar Hariharan, who is leaving Amneal on May 24. Pradeep joins Amneal from Apotex.

07:09 EDT Walgreens Boots Alliance down 6.4% after reporting Q2 results, cutting guidance

07:08 EDT Rexford Industrial issued an aggregate of 7M shares during the last quarter - Rexford Industrial Realty announced that, under its "At the Market" stock offering program, or ATM, the Company issued an aggregate of 7,148,746 shares of common stock during the quarter ending March 31. The shares were issued at a weighted average offering price of $34.75 per share, receiving gross proceeds of approximately $248.4M and net proceeds of approximately $244.7M. The Company used the net proceeds of the ATM to fund acquisitions, for working capital and other general corporate purposes.

07:07 EDT ContraFect CEO Steven Gilman to retire, Roger Pomerantz to succeed - ContraFect (CFRX) announced that Roger Pomerantz has been appointed chairman and CEO of ContraFect and will succeed Steven Gilman, who is retiring from his position as Chairman and CEO. Pomerantz was most recently chairman and CEO of Seres Therapeutics (MCRB), a company focused on therapeutics that regulate the microbiome, where he now continues as the company's chairman of the board.

07:06 EDT TuanChe to conduct non-deal roadshow frm April 8-April 19 - TuanChe Limited announced that the company has scheduled a Non-Deal Roadshow from Monday, April 8, 2019 to Friday, April 19, 2019. During the NDR, executives from the company, including Wei Wen, the company's CEO, and Zhihai Mao, the company's CFO, plan to visit Boston, New York, Chicago, San Francisco, and Los Angeles to meet with institutional investors.

07:05 EDT Sangamo, Pfizer announces interim data from Phase 1/2 Alta study - Sangamo Therapeutics (SGMO) and Pfizer (PFE) announced interim data from the Phase 1/2 Alta study evaluating investigational SB-525 gene therapy for severe hemophilia A. Data indicate that SB-525 was generally well-tolerated and demonstrated a dose-dependent increase in Factor VIII levels across the four dosage cohorts. Eight patients total were dosed. Based on these results, the Safety Monitoring Committee recommended cohort expansion at the 3e13 vg/kg dose.

07:05 EDT Trillium expands immuno-oncology pipeline with STING agonist program - Trillium Therapeutics announced that it has expanded its immuno-oncology pipeline with a STING agonist program and presented preclinical data from this program at the 2019 Annual Meeting of the American Association for Cancer Research. Trillium's AACR presentation described TTI-10001, a novel small molecule STING agonist that exhibits favorable potency, cell permeability, and tumor retention properties that could potentially overcome the common limitations of current CDN-derived STING agonists. TTI-10001 is well tolerated in mice at relevant doses after intratumoral or intravenous delivery. Upon intratumoral administration, TTI-10001 monotherapy induced complete regressions in both injected and distal tumors and protected mice from subsequent tumor challenge, demonstrating the induction of durable immunity.

07:04 EDT Casi Pharmaceuticals names Wei-Wu He, Ph.D as CEO, succeeding Ken Ren - CASI Pharmaceuticals announced that Wei-Wu He, Ph.D., Executive Chairman of CASI, has been appointed CEO. Dr. He will continue to serve as Chairman of the Board of Directors. Dr. He succeeds Ken Ren, Ph.D. who for personal reasons is stepping down from his role as CEO but will remain on the company's Board of Directors. Prior to joining CASI as CEO, Dr. He had a very successful career building companies from early to revenue and profit stages. Most recent from his track record was serving as CEO of OriGene Technologies.

07:02 EDT Stonepeak Infrastructure Partners to acquire Oryx Midstream for $3.6B

06:56 EDT Aecom announces $750M contract extension with DOE in South Carolina - AECOM announced that the U.S. Department of Energy's, or DOE's, Savannah River Operations Office in Aiken, South Carolina, extended the current liquid waste management contract with AECOM-led Savannah River Remediation. The approximate $750M extension will run from April 1, to September 30, 2020. The value of the contract extension was included in AECOM's backlog in the Q2.During the contract extension period, services that the AECOM-led joint venture will perform are operating the Defense Waste Processing Facility and Saltstone Production Facility, and continuing progress on the Tank Closure Cesium Removal demonstration and construction project and the construction of Saltstone Disposal Unit 7.

06:55 EDT Synthesis Energy Systems trading halted, news pending

06:47 EDT DPW Holdings terminates At-The-Market Issuance Sales Agreement - DPW Holdings announced that it has sent a notice to Wilson-Davis & Co. terminating the At-The-Market Issuance Sales Agreement, dated October 15, 2018, by and between itself and Wilson-Davis. The effective date of the termination is April 1, 2019. Sales of common stock sold pursuant to the Agreement were registered on the company's effective shelf registration statement on Form S-3 and an accompanying base prospectus contained therein (Registration Statement No. 333-222132) filed with the SEC on December 18, 2017, amended on January 8, 2018, and declared effective by the SEC on January 11, 2018, and a prospectus supplement related to the ATM Offering, dated October 15, 2018.

06:46 EDT UGI Corporation, AmeriGas merger expected to close in Q4 - UGI (UGI) which does not currently have debt at the corporate level, plans to finance the cash portion of the transaction by entering into a bank term loan of approximately $500M. The merger is not, however, subject to any financing condition. This transaction is subject to the approval of AmeriGas' (APU) unitholders, as well as the satisfaction of customary closing conditions. The transaction is expected to close in the fourth quarter.

06:37 EDT UGI Corporation to raise Q2 dividend by 15% to 30c from 26c per share - UGI plans to increase its second fiscal quarter dividend by 15% (an increase from 26c to 30c) and an additional 10% (an increase from 30c-32.5c) following the closing of the transaction.

06:34 EDT UGI Corporation to acquire 100% of publicly held units of AmeriGas - UGI Corporation (UGI) and AmeriGas Partners, L.P. (APU) announced that they have entered into a merger agreement under which UGI will fully consolidate its ownership of AmeriGas, the nation's largest retail propane marketer, by acquiring the 69.2M publicly held common units it does not already own. Under the terms of the agreement, AmeriGas unitholders will receive 0.50 shares of UGI common stock plus $7.63 in cash consideration for each common unit of AmeriGas, representing a premium of 21.9% to AmeriGas' 30-day volume weighted average price and a 13.5% premium to the April 1 closing price of $31.13. AmeriGas unitholders will continue to receive a 95c per unit distribution for each quarter completed prior to the closing of the merger. As part of the transaction, AmeriGas will no longer be a Master Limited Partnership and will instead become a wholly owned subsidiary of UGI. UGI currently holds an approximate 26% ownership interest in AmeriGas. AmeriGas Propane, Inc., a wholly owned UGI subsidiary, has served as AmeriGas' sole general partner since 1995. The General Partner's Audit Committee, comprised entirely of independent directors, after consultation with its independent legal and financial advisors, unanimously approved the merger agreement and determined it to be fair and reasonable to, and in the best interests of, AmeriGas and the unitholders unaffiliated with UGI. Subsequently, the transaction was approved by the Boards of both UGI and the General Partner. The closing of the merger is subject to satisfaction of customary conditions. Under the partnership agreement, the merger is required to be approved by a majority of the outstanding AmeriGas common units. Affiliates of UGI own approximately 26% of the outstanding common units and have entered into a support agreement with AmeriGas whereby they have agreed to vote their common units in favor of the transaction.

06:32 EDT Wabco appoints Sean Deason as CFO - WABCO Holdings announced that it has appointed Sean Deason to the role of CFO, effective immediately. Deason replaces Roberto Fioroni, who tendered his resignation after accepting a role outside WABCO with GKN Automotive, a Melrose owned business in the UK. Deason joined WABCO in June 2015 and has served as Vice President, Investor Relations and Controller. Prior to joining WABCO, Deason spent four years with Evraz, where he was Vice President, Financial Planning & Analysis. Prior to that, he spent twelve years with Lear Corporation where he served as Director, Finance, Corporate Business Planning & Analysis, Director, Finance, Asia Pacific Operations, Assistant Treasurer, as well as holding other positions of increasing responsibility from August 1999.

06:31 EDT Senior Housing and Five Star Senior Living to restructure business arrangements - Senior Housing Properties Trust (SNH) announced that it has entered into a definitive agreement to modify its existing business arrangements with Five Star Senior Living (FVE), or Five Star. Effective January 1, 2020, the existing five master leases for 184 of SNH's senior living communities that are leased to Five Star as well as the existing management agreements and pooling agreements with Five Star for 77 of SNH's senior living communities will be terminated and replaced with new management agreements for all 261 Five Star operated senior living communities. Simultaneous with the conversion of SNH's existing agreements with Five Star into new management agreements with Five Star, SNH and SNH shareholders will receive Five Star common shares equal to approximately 85% ownership of Five Star in aggregate after taking into account SNH's current ownership. As part of the transaction, SNH shareholders will receive, by way of a distribution of the right to receive Five Star common shares from SNH and subject to certain conditions, Five Star common shares equal to approximately 51% ownership of Five Star post issuance, effective as of January 1, 2020. SNH will also increase its current 8.3% ownership of Five Star to approximately 34% post issuance. SNH currently plans to retain this ownership of Five Star for the foreseeable future. Morgan Stanley is acting as exclusive financial advisor to the special committee of SNHs Board of Trustees and Sullivan & Worcester is acting as legal counsel to the special committee of SNHs Board of Trustees in this transaction.

06:11 EDT UKAR announces GBP4.9B sale of NRAM assets to Citi - Following an open and competitive process, NRAM Ltd, part of UK Asset Resolution Limited, confirms that it has agreed to sell two separate portfolios of residential owner-occupied mortgages and unsecured loans to Citi for a total of GBP4.9B. The majority of financing for the transaction is being provided by PIMCO. Financial completion is expected within the next few weeks and will enable UKAR to repay all outstanding government loans to HM Treasury. The sale is based on the portfolio position as at September 30, 2018, from which point the purchaser will acquire the risks and rewards of ownership of approximately 66,000 NRAM loans.

06:08 EDT GDS Holdings announces launch of AWS Direct Connect in Shanghai, Shenzhen - GDS Holdings (GDS) announced the launch of Amazon Web Services (AMZN) Direct Connect in GDS's Shanghai and Shenzhen data centers. Through AWS Direct Connect, customers can directly access AWS over a private, enterprise-grade network connection, which helps customers reduce data transfer costs, improve network security, and achieve consistent network performance. This deployment represents the first and only native points of connectivity to AWS Direct Connect available in Shanghai and Shenzhen, two of the most important markets in China.

06:05 EDT Lear to acquire Xevo for $320M - Lear announced it has entered into a definitive agreement to acquire Seattle-based Xevo, an automotive software supplier that develops solutions for cloud, car and mobile devices. Xevo's Journeyware suite of products combines an interface with a cloud-based framework that allows drivers to interact with in-car content and mobile applications utilizing real-time data. Xevo Market, an automotive commerce and services platform, connects consumers with food, fuel, parking, hotel and retail brands through in-vehicle touchscreens and OEM-branded mobile applications. Xevo's technology is currently available in over 25M vehicles located primarily in the U.S., with opportunity for expansion not only in North America, but also in Asia and Europe. Lear will acquire all the outstanding shares of Xevo for $320M. The transaction, which is subject to regulatory approvals and other customary closing conditions and adjustments, is expected to close in Q2. Lear intends to fund the transaction through a debt financing.

06:03 EDT Ensign Group acquires Arizona skilled nursing facility - Ensign Group announced that it acquired the real estate and operations of Phoenix Mountain Post Acute, a skilled nursing facility with 130 skilled nursing beds located in Phoenix, Arizona. The acquisition was effective April 1. In a separate transaction on the same day, Ensign announced that it acquired through Ensign's senior living services portfolio company, the real estate and operations of Rockbrook Memory Care, a 52-unit memory care community in Lewisville, Texas. The Rockbrook acquisition was also effective April 1.

05:45 EDT Achieve Life Sciences announces completion of second DSMB review of ORCA-1 trial - Achieve Life Sciences announced that the Data Safety Monitoring Committee, or DSMC, met on March 28, 2019 to conduct its second and final safety review of the ORCA-1 Trial. The DSMC is an independent committee that advises on continuation or stopping of clinical trials based upon safety and study conduct considerations. The ORCA-1 DSMC has had the responsibility for safeguarding the interests of trial subjects by assessing the safety of the interventions and monitoring the conduct of the ORCA-1 trial. The committee has reviewed the ORCA-1 data twice during the conduct of the study, and has concluded following each review that there are no safety concerns for subjects or study conduct issues, and the trial should continue for completion as planned. ORCA-1 topline efficacy and safety data are expected to be announced by end of the second quarter of 2019. "We are very pleased with the speed of enrollment and efficient conduct of the ORCA-1 trial, which is attributed to the commitment of the trial subjects, clinical investigators and their support teams," said Dr. Cindy Jacobs, Chief Medical Officer at Achieve. "We look forward to sharing the data results in the near future."

05:33 EDT NIO Inc. reports 3,989 ES8 deliveries in Q1 - NIO Inc. provided its delivery results for Q1. As of March 31, 2019, aggregate deliveries of the company's ES8, its 7-seater, high-performance premium electric SUV, reached 15,337 vehicles, 3,989 of which were delivered in Q1. 1,373 ES8s were delivered in March, a 69.3% increase over February deliveries of 811, which were negatively impacted by the slow down surrounding the Chinese New Year holiday and the related closures of automobile license plate registration offices. The company delivered 1,805 ES8s in January, 811 in February and 1,373 in March, bringing the total deliveries of ES8s to 3,989 in Q1. Q1 ES8 deliveries exceeded the company's prior guidance range of 3,500 to 3,800, and were above the midpoint of the guidance range, 3,650, by 339 vehicles, or 9.3%.

05:14 EDT Novartis announces Chinese approval of Cosentyx for psoriasis patients - Novartis announced that the China Health Authority NMPA approved Cosentyx, the first-in-class interleukin-17A inhibitor for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. "Reimagining the management of psoriatic disease to provide patients with the ability to live their life free from the burden of psoriasis is a key focus for us," said Paul Hudson, CEO Novartis Pharmaceuticals. "With Cosentyx, we are offering a new treatment to doctors and psoriasis patients in China which can act within 3 weeks, has demonstrated sustained safety in more than 200,000 patients worldwide and can deliver what doctors and patients are looking for."