Stockwinners Market Radar for January 03, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:16 EDT Neovasc discloses Nasdaq notice on market value deficiency - Neovasc announced that it has received written notification from The Nasdaq Stock Market notifying the company that it is not in compliance with the minimum market value requirement set forth in Nasdaq Rules for continued listing on the Nasdaq Capital Market. Based on the market value of the Company for the 30 consecutive business days from November 16, 2018 to January 2, 2019, the company no longer meets the minimum market value requirement. In accordance with Nasdaq Listing Rule 5810, the Company has been provided 180 calendar days, or until July 2, 2019, to regain compliance with Nasdaq Listing Rules.

18:47 EDT Great Lakes Dredge receives $93M Corpus Christi Channel deepening award - Great Lakes Dredge & Dock Corporation announced the receipt of a $93M contract award for the Corpus Christi Ship Channel Improvement Project. Dredging to deepen the entrance channel will commence during the second quarter of 2019 with completion expected in early 2020. The overall ship channel deepening effort will be comprised of multiple phases, expected to be competitively bid and worked over the next five years. The total estimated contract value of these projects is approximately $360M.

18:12 EDT Aquestive Therapeutics names Gary H. Slatko chief medical officer - Aquestive Therapeutics, Inc. announced the appointment of Gary H. Slatko as SVP, Chief Medical Officer. Dr. Slatko will lead clinical and medical affairs for the company, and is reporting to CEO Keith J. Kendall, effective January 2, 2019. "We are pleased to have Dr. Slatko join Aquestive and further our work in improving medications and outcomes for patients," said Keith J. Kendall, Chief Executive Officer of Aquestive Therapeutics. "Dr. Slatko's experience at the FDA and in the pharmaceutical industry will benefit Aquestive's entire proprietary pipeline, including our late-stage development programs, Libervant(TM) (diazepam) buccal film and Exservan oral film. Additionally, his depth of medical experience will be beneficial to our commercial teams as we engage with physicians and nurses to raise awareness of Sympazan, which launched late last year." Dr. Slatko's experience includes six years in drug safety regulatory work at the U.S. Food and Drug Administration as a director in the Office of Medication Error Prevention and Risk Management.

17:45 EDT Generex partner Olaregen in pacts for Excellagen with Collagen Solutions - Earlier today, Generex Biotechnology announced that its partially, soon to be fully-owned subsidiary, Olaregen Therapeutix has signed critical manufacturing agreements for Excellage with Collagen Solutions, a highly-regarded supplier of medical grade collagen biomaterials for use in research, medical devices, and regenerative medicine applications, and with Berkshire Sterile Manufacturing, a state-of-the art, GMP fill/finish manufacturer providing formulation and sterile filling as well as analytical development and stability services to the biotech and pharmaceutical industries. The two contract manufacturers will produce and package Excellagen in two dose formulations for the initial product launch in the first quarter of 2019, with a third dosage option for large wounds to follow shortly thereafter.

17:36 EDT MarketAxess reports December trading volume of $131.2B - MarketAxess Holdings announced total monthly trading volume for December 2018 of $131.2B, consisting of $74.4B in U.S. high-grade volume, $52.4B in other credit volume, and $4.4B in liquid products volume. The company also reported preliminary total variable transaction fees per million of $173 for the quarter ended December 31. The FPM for the quarter ended December 31, 2018 are preliminary and may be revised in subsequent updates and public filings.

17:31 EDT Brown & Brown names Cousins Properties CEO to board of directors - Brown & Brown, Inc. (BRO) has announced the addition of Lawrence L. Gellerstedt III, chairman of the board and Chief Executive Officer of Cousins Properties Incorporated (CUZ), a fully integrated, self-administered, and self-managed real estate investment trust based in Atlanta, Georgia, to Brown & Brown, Inc.'s board of directors. Gellerstedt has served as Chairman of the Board and Chief Executive Officer of Cousins Properties Incorporated (Cousins) since July 2017.

17:25 EDT Chiasma anticipates submission of NDA for Mycapssa by 2019-end - Chiasma previewed anticipated upcoming corporate milestones and commented on the significant progress made by the company in 2018."During 2018, we completed the required enrollment in both of our Phase 3 clinical trials of our investigational octreotide capsules product candidate, which we have conditionally trade-named Mycapssa, and with those trials progressing as planned, we believe we have set the stage for a catalyst-rich 2019 including the announcement of topline data evaluating Mycapssa's efficacy as potentially the first oral somatostatin analog for the maintenance therapy of adult acromegaly patients," said Mark Fitzpatrick, President and Chief Executive Officer of Chiasma. "As we enter the new year, our plans are firmly in place, assuming positive Phase 3 CHIASMA OPTIMAL data, to submit an NDA by the end of 2019 with an eye toward possible FDA approval of Mycapssa in mid-2020." "Multiple publications as well as initial screening data from Chiasma's MPOWEREDTM clinical trial have highlighted the undesirable treatment burden associated with monthly injectable somatostatin receptor ligands, the current standard of care in the chronic treatment of adults with acromegaly. Based on this data and feedback from physicians and patients, an alternative orally administered therapeutic option could alleviate this burden for some patients. We believe Mycapssa, if approved as the first oral somatostatin analog, has the potential to become a standard of care in acromegaly maintenance treatment. In anticipation of positive clinical trial results in 2019, we intend to meaningfully transition into commercial readiness planning in 2019," Mr. Fitzpatrick concluded.

17:18 EDT Aquilo Capital Management reports 6.4% passive stake in Merus

17:13 EDT Selecta Biosciences announces work force reduction - On December 21, the board of Selecta Biosciences approved a plan to reduce Selecta's headcount by approximately 36% following a strategic review of the company's business. The Workforce Reduction aims to align Selecta's workforce with the company's newly announced strategy to focus on the development of the company's lead product candidate, SEL-212, for the treatment of chronic refractory gout, and advancement of the company's ImmTOR technology in the area of gene therapy, specifically ImmTOR in combination with AAV gene therapy for the treatment of Crigler-Najjar Syndrome, as well as the deprioritization of the company's oncology development program. While the Workforce Reduction generally affects employees in all areas of Selecta, primarily affected are those working in research and related general and accounting functions. The Workforce Reduction resulted in the termination of approximately 17 employment positions effective January 3 and the affected employees were notified on the same date. Following the Workforce Reduction, Selecta expects to have approximately 45 full-time employment positions and to be appropriately resourced to continue executing on its current strategy. Selecta estimates that it will incur aggregate charges in connection with the Workforce Reduction of approximately $488,000 for employee severance and termination benefit costs, all of which are expected to be cash expenditures. Selecta expects to substantially complete the Workforce Reduction during the first quarter of 2019.

17:02 EDT Chase Corporation CFO Kenneth Feroldi to step down, Christian Talma to succeed - Kenneth Feroldi, treasurer and CFO of Chase Corporation said, "On a personal note, I have completed my 28th year with the Company and my 4th year as Chief Financial Officer and Treasurer of Chase Corporation, having spent the majority of the prior two decades in a similar role at our subsidiary NEPTCO. I remain grateful to Adam and Peter Chase and our Board of Directors for the opportunity to serve in this role and am thankful for the dedicated and hard-working associates I have had the pleasure and honor of working alongside. The growth the Company achieved during my time here was rewarding and I was fortunate to have played a role. This past August, Chase welcomed Christian J. Talma into the newly created role of Chief Accounting Officer, and I am pleased with the speed and thoroughness with which he has gained an understanding of the Company and the trust of our associates. Effective with our annual shareholders meeting scheduled for February 5, 2019, and subject to final board approval at that time, Christian will be named Chief Financial Officer, while I will retain the role of Treasurer. Our plan is for me to work closely with Christian through this transition, while remaining an executive officer and employee of the Company."

17:01 EDT Owens Corning names Brian Chambers CEO to succeed Mike Thaman - Owens Corning announced that its board of directors elected Brian D. Chambers current President and Chief Operating Officer, to succeed Mike Thaman as Chief Executive Officer, effective April 18, 2019. Thaman, who has served as Chairman since 2002 and as CEO since 2007, announced his retirement as CEO and will remain with the company in the role of Executive Chairman.

16:56 EDT Unity Biotechnology selects UBX1967 as lead ophthalmology candidate - Unity Biotechnology has selected UBX1967 as the lead development candidate in the ophthalmology pipeline for advancement into studies to enable an Investigational New Drug application and executed the compound license agreement for the compound with Ascentage Pharma under a previously agreed compound library agreement. UBX1967 is being evaluated in a range of age-related diseases of the eye, including neovascular age-related macular degeneration, proliferative diabetic retinopathy and diabetic macular edema. Unity plans to file an IND application for UBX1967 in 2H19.

16:53 EDT Broadfin Capital reports 5.3% passive stake in Neos Therapeutics

16:48 EDT Unitil announces retirement of CFO Mark Collin - Unitil Corporation announced the planned retirement of Mark Collin, senior VP, CFO and Treasurer, effective May 1. Concurrently, Unitil announced the hiring of Christine Vaughan as senior VP, Financial and Regulatory Services, effective January 2, as Collin's planned successor. Vaughan will assume the title of senior VP, CFO and Treasurer of the company on March 1, 2019.

16:41 EDT Novavax spikes as high as 12% after announcing positive results for NanoFlu - Shares of Novavax are spiking in the after-hours after announcing top-line results of its Phase 2 clinical trial of NanoFlu. The trial compared the safety and immune responses of various quadrivalent formulations of NanoFlu, with or without Novavax' Matrix-M adjuvant, with two U.S.-licensed influenza vaccines in 1,375 healthy adults 65 years of age and older. Shares are currentlu up 9.5% in after-hours trading to $2.23 per share.

16:33 EDT Calyxt appoints William Koschak as CFO - Calyxt announced the hiring of William Koschak, as CFO of Calyxt, effective January 7. Koschak will be assuming the responsibilities of current interim CFO, Eric Dutang, who remains CFO of Cellectis, Calyxt's parent company.

16:31 EDT Retrophin names Eric Dube, Ph.D. President and CEO - Retrophin announced the appointment of Eric Dube, Ph.D. as president and CEO, effective January 4, 2019. Dr. Dube joins Retrophin from ViiV Healthcare, where he served as president of North America, and brings a successful track record of global leadership with significant expertise in delivering innovative therapies to address unmet patient needs. He will also serve as a member of Retrophin's Board of Directors. Dr. Dube succeeds Stephen Aselage who has served as CEO since 2014 and previously announced his planned retirement. Aselage will continue to serve as a member of the Retrophin Board of Directors.

16:29 EDT Zagg sees HALO acquisition as immediately accretive to gross margins

16:24 EDT New Mountain Finance extends share repurchase plan to up to $50M - New Mountain Finance has authorized an extension of a program for the purpose of repurchasing up to $50M worth of its common stock. Unless further extended by the board, the company expects the repurchase program to be in place until the earlier of December 31, 2019 or until $50M worth of NMFC's outstanding shares of common stock have been repurchased. To date, approximately $2.9M worth of repurchases have been made by the company under the repurchase program.

16:19 EDT Highwoods Properties sells two properties for $54.5M - Highwoods Properties has sold Two Point Royal, a 124,000 square foot building in Alpharetta, GA, and Highwoods Preserve I, a 199,000 square foot, single customer building in northeast Tampa, for combined gross proceeds of $54.5M. These sales closed subsequent to October 23, 2018, the date of Highwoods Q3 earnings release. These two office properties were 91% occupied upon sale and were expected to generate $4.2M of annual GAAP net operating income in 2019. Highwoods will continue to serve as property manager of Highwoods Preserve I in exchange for customary fees. The company will record non-FFO gains of approximately $20.7M in Q4 of 2018 in connection with these sales.

16:18 EDT HFF Inc announces $100M sale of resort hotels in St. Pete Beach, FL - Holliday Fenoglio Fowler announces the $100 million sale of the Grand Plaza Hotel and the Beachcomber Beach Resort and Hotel, two waterfront hotels totaling 258 rooms in St. Pete Beach, Florida. The HFF team marketed the hotels on behalf of the seller, Excel Hospitality Inc. The hotels are a quarter mile apart and span across a combined 9.98 acres with approximately 450 linear feet of Gulf frontage on St. Pete Beach, which was ranked the 2018 No. 7 "Best Beach in the U.S." by TripAdvisor and is a former No. 1 "Best Beach in the U.S."

16:16 EDT Mercury Systems secures $40M design win - Mercury Systems announced it secured a design win for advanced, safety certifiable flight controllers from an international aerospace company with an anticipated lifetime value of $40M over the ten-year period of the contract. An initial $9M contract received in the company's Q2 also includes funding for ground support processing segments, and work will be performed through fiscal 2020.

16:16 EDT Ford urges shareholders to reject mini-tender offer by Baker Mills - Ford Motor Company received notice of an unsolicited mini-tender offer by Baker Mills LLC, a Delaware limited liability company, to purchase up to 400,000 shares of common stock, par value 1c per share, of Ford, representing approximately 0.010 percent of the company's outstanding common stock. Baker Mills' offer price of $7.00 per share in cash is approximately 17.84% lower than the $8.52 closing price of Ford common stock on Dec. 14, 2018, the last closing price prior to commencement of the offer. Ford said it is not associated with this mini-tender offer and does not endorse Baker Mills' unsolicited offer. Ford recommends against shareholders tendering their shares in response to Baker Mills' offer because the offer is at a price below the current market price of Ford common stock. Ford is not affiliated or associated in any way with Baker Mills, its mini-tender offer, or the mini-tender offer documentation.

16:12 EDT Novavax announces results from Phase 2 NanoFlu trial - Novavax announced top-line results of its Phase 2 clinical trial of NanoFlu. The trial compared the safety and immune responses of various quadrivalent formulations of NanoFlu, with or without Novavax' Matrix-M adjuvant, with two U.S.-licensed influenza vaccines in 1,375 healthy adults 65 years of age and older. All formulations of NanoFlu were well-tolerated and elicited vigorous immune responses to the four strains included in the vaccine. Matrix-M adjuvant resulted in significant enhancement of immune responses when compared to the unadjuvanted formulation. NanoFlu is a differentiated flu vaccine, as evidenced by superior hemagglutination inhibition antibody responses against wild-type A viruses, including drifted strains, when compared to Fluzone High-Dose, the leading flu vaccine in older adults. NanoFlu formulation identified for the Phase 3 clinical trial and commercialization. As Novavax previously announced, the FDA acknowledged that the accelerated approval pathway may be available for NanoFlu, which could allow for licensure of NanoFlu in a shorter timeframe. Novavax will again meet with the FDA in the first half of 2019 to discuss the Phase 2 clinical trial data, the proposed Phase 3 trial design, and the use of accelerated approval for licensure.

16:10 EDT 683 Capital Partners reports 5.5% passive stake in Miragen Therapeutics - In a regulatory filing, 683 Capital Partners disclosed a 5.5% stake in Miragen Therapeutics, which represents roughly 1.7M shares. The filing does not allow for activism.

16:08 EDT Flexion CEO comments first full year launch of Zilretta - "2018 was a foundational year for ZILRETTA, and in the first full year of the launch, we saw strong product uptake as we established a broad and growing base of prescribers. Furthermore, the clinical feedback on ZILRETTA from physicians and patients alike continues to be overwhelmingly positive and gratifying," said Michael Clayman, M.D., President and Chief Executive Officer. "We now enter 2019 with a product-specific J code, which we believe will be a key driver of continued ramp, as it provides prescribers with a well-known and clearly defined reimbursement mechanism that is utilized by both Medicare and private payers. Each year, roughly five million people in the U.S. receive intra-articular injections for osteoarthritis knee pain, and we believe ZILRETTA will play an increasingly significant role in the treatment paradigm for this large and growing patient population."

16:07 EDT Jazz Pharmaceuticals, Codiak BioSciences announce strategic collaboration - Jazz Pharmaceuticals and Codiak BioSciences announced that the companies have entered into a strategic collaboration agreement focused on the research, development and commercialization of exosome therapeutics to treat cancer. Codiak granted Jazz an exclusive, worldwide, royalty-bearing license to develop, manufacture and commercialize therapeutic candidates directed at five targets to be developed using Codiak's engEx precision engineering platform for exosome therapeutics. The targets focus on oncogenes that have been well validated in hematological malignancies and solid tumors but have been undruggable with current modalities, including NRAS and STAT3. Under the terms of the agreement, Codiak is responsible for the execution of pre-clinical and early clinical development of therapeutic candidates directed at all five targets through Phase 1/2 proof of concept studies. Following the conclusion of the applicable Phase 1/2 study, Jazz will be responsible for future development, potential regulatory submissions and commercialization for each product. Codiak has the option to participate in co-commercialization and cost/profit-sharing in the U.S. and Canada on up to two products. As part of the agreement, Jazz will pay Codiak an upfront payment of $56M. Codiak is eligible to receive up to $20M in preclinical development milestone payments across all five programs. Codiak is also eligible to receive milestone payments totaling up to $200M per target based on Investigational New Drug application acceptance, clinical and regulatory milestones, including approvals in the U.S., European Union and Japan, and sales milestones. Codiak is also eligible to receive tiered royalties on net sales of each approved product, with percentages ranging from mid-single digits in the lowest tier to high teens in the highest tier.

16:06 EDT Interface announces new restructuring plan, eliminates 200 staff positions - In a regulatory 8-k filing, Interface stated: "On December 28, 2018, Interface committed to a new restructuring plan as part of its continuing efforts to improve efficiencies and streamline operations to more closely align its operating structure with its business and value creation strategy. The plan involves (i) a reduction of approximately 200 positions globally and (ii) the write-down of certain obsolete, underutilized and impaired information technology and manufacturing assets. As a result of this plan, the Company expects to incur a pre-tax restructuring and asset impairment charge in the fourth quarter of 2018 of approximately $22.0 million. The restructuring plan is expected to be substantially complete in the first half of 2019. The plan is expected to yield gross annual savings of approximately $12.5 million, however; the Company expects to redeploy essentially all of the anticipated savings toward the funding of sales and strategic growth initiatives and those investments will start in 2019 yielding negligible net savings on the Company's income statement."

16:04 EDT Prospect Capital CEO acquires 299,707 common shares - In a regulatory filing, Prospect Capital CEO John F. Barry disclosed the purchase of 299,707 common shares of the company at a price of $6.31 per share.

15:45 EDT American Midstream Partners trading halted, news pending

15:19 EDT Moody's reviews Bristol-Myers Squibb for potential downgrade - Moody's Investors Service reports that it placed the ratings of Bristol-Myers Squibb (BMY) under review for downgrade, including the A2 senior unsecured long-term rating and the Prime-1 commercial paper rating. This rating action follows the announcement that Bristol will acquire Celgene (CELG) in a transaction valued at approximately $74B plus debt and contingent value rights. The acquisition is subject to regulatory reviews and shareholder approvals and is expected to close in the third quarter of 2019. "The review for downgrade reflects higher financial leverage resulting from the acquisition, as well as pipeline execution risk and integration risks. Moody's anticipates that pro forma debt/EBITDA at the time the acquisition closes will be close to 4.0x. However, significant deleveraging opportunities will arise from earnings growth and free cash flow, a portion of which Moody's believes Bristol will use to repay debt. As a result, Moody's anticipates debt/EBITDA will decline below 3.0x within two years of the deal's close," the ratings service stated.

14:21 EDT Andrew M. Cohn reports 8.4% passive stake in Global Water Resources - In a regulatory filing, Andrew M. Cohn disclosed an 8.4% stake in Global Water Resources, which represents roughly 1.8M shares. The filing does not allow for activism.

13:31 EDT Brandywine Realty announces $150M share repurchase program - Brandywine Realty Trust announced that its Board of Trustees has authorized the repurchase of up to $150M of the Company's common shares. Repurchases may be made at management's discretion from time to time on the open market or through privately negotiated transactions. The repurchase program has no time limit and may be suspended for periods or discontinued at any time.

13:14 EDT Yelin Lapidot Holdings reports 5.03% passive stake in B Communications Ltd. - In a regulatory filing, Yelin Lapidot Holdings Management disclosed a 5.03% stake in B Communications, which represents about 1.5M shares. The filing does not allow for activism.

13:07 EDT Vistra Energy unit Luminant says Upton 2 battery storage system operational - Luminant, a subsidiary of Vistra Energy, announced that its Upton 2 battery energy storage system project has finished construction and began operating on Dec. 31. The battery system, which is the largest energy storage project in Texas and seventh largest in the United States, is located on the site of Luminant's 180-megawatt Upton 2 Solar Power Plant in Upton County, Texas. The solar facility continues to deliver on the company's strategic plan to strengthen and expand its integrated businesses through enhanced retail solar offerings and diversity across its generation fleet. It is also direct evidence that competitive generators will invest in batteries in Texas when supported by market economics. Vistra is also currently developing the world's largest battery energy storage project, the 300-MW/1,200-MWh storage system at its Moss Landing Power Plant in California, scheduled for commercial operations in the fourth quarter of 2020.

12:58 EDT Career Education reaches agreements with 48 states, sees $6.3M charge - Career Education announced that it has reached agreements with attorneys general from 48 states and the District of Columbia to bring closure to the multi-state attorneys general inquiry on-going since January 2014. As part of the agreements the company denied any allegations of wrongdoing or liability. In addition, the attorneys general have provided a release of potential claims that they may have brought. In connection with these agreements, Career Education expects to record a total pre-tax charge of $6.3M, consisting of a $5M payment to the attorneys general to cover expenses incurred during the course of their inquiry over the last five years and the write-off of approximately $1.3M of accounts receivable. It added, "Although the Company agreed to forgo efforts to collect on approximately $556 million of old accounts receivable that were incurred during the last 30 years by students at more than 100 campuses who reside in participating states, all but approximately $1.3 million of these old accounts receivable were written-off in prior reporting periods in the ordinary course of the Company's operations. The agreement to forgo efforts to collect on previously written-off receivables does not require additional write-off expense to the Company's financial statements." Career Education will work with a third-party administrator over the next three years who will provide ongoing oversight and review of the company's implementation of the terms of the agreements. The vompany will reimburse the administrator a total of $2M for fees and expenses to be paid over the next three years.

12:29 EDT Whole Foods launches digital catalog to tailored to dietary preferences - Whole Foods Market launches a digital product catalog on wholefoodsmarket.com that allows shoppers to find items by dietary preference and provides complete nutritional information and ingredient lists at customers' fingertips. According to a recent Whole Foods Market study, almost one third of frequent customers say they shop according to a specific dietary preference. The optimized site is a quick and convenient way for those shoppers to research food options and verify availability at their local store. "Whole Foods Market has always been a go-to for those who follow special diets or want greater transparency into what they are eating," said Jason Buechel, Executive Vice President of Technology and Chief Information Officer for Whole Foods Market. "This new experience makes it easier than ever for those customers to find products that fit their needs from dietary preferences to lifestyle changes, and ultimately helps them achieve their wellness goals." Whole Foods is owned by Amazon. Reference Link

12:09 EDT Volvo to take SEK 7B provision in Q4 for emission issue - Volvo Group said that previously communicated, it has detected an emissions control component used in certain markets and models may degrade more quickly than expected, affecting the vehicles emission performance negatively. Volvo announced today that it will in Q4 make a provision of SEK 7B, relating to the estimated costs to address the issue. "The estimated costs are based on several factors such as testing of vehicles, statistical analysis and dialogue with relevant authorities. The next step will be to define how to implement corrective actions concerning the component in vehicles affected by this issue. This will be done together with the relevant authorities," Volvo stated. It added, "The degradation of the component in question does not pose a product safety issue, nor does it negatively affect vehicle or engine performance in areas other than emissions control. The degradation is a result of a materials issue that occurs over time. All engines and vehicles equipped with the component meet emissions limits at delivery. The provision will impact operating income in the fourth quarter of 2018, while the negative cash flow effect will start in 2019 and gradually ramp up in the coming years. The Volvo Group will continuously assess the size of the provision as the matter develops."

12:01 EDT Apple says holiday week 'biggest week ever' for App Store with over $1.22B spent

12:00 EDT Bristol-Myers falls -11.7% - Bristol-Myers is down -11.7%, or -$6.08 to $45.94.

12:00 EDT Dynagas LNG rises 8.9% - Dynagas LNG is up 8.9%, or 33c to $4.04.

12:00 EDT Park Electrochemical rises 11.5% - Park Electrochemical is up 11.5%, or $2.12 to $20.54.

11:32 EDT One Stop Systems receives $4M follow-on purchase order from OEM - One Stop Systems has received a $4M purchase order with a $1M customer extension option from a major OEM in the media and entertainment industry. The follow-on order, the largest ever received by OSS, is for high-performance media servers that drive large format high-definition video displays at major entertainment venues, like concerts, award shows and sporting events. They feature high-bandwidth networking and ultra-fast flash storage in a ruggedized chassis. OSS plans to begin initial shipments this month, with shipments expected to be completed during the first half of 2019.

10:53 EDT Honda reports December U.S. sales up 3.9% to 155,115 vehicles - Honda finished 2018 on a strong note with both cars and trucks gaining in December, overcoming over four months of lost production due to a flood that shut the Celaya, Mexico auto plant to narrowly miss a new annual sales mark. Truck sales set new monthly and annual records led by CR-V which set an all-time monthly record, with 42,079 units in December, a gain of 13.8%. Pilot set a new annual mark, eclipsing its previous record by over 7,000.

10:36 EDT Maiden Holdings reports amendment to quota share deal with AmTrust - Maiden Holdings announced that it mutually agreed with AmTrust Financial Services to a partial termination amendment to the Maiden Quota Share Agreement that is currently in-force and is set to expire on June 30, 2019. The amendment provides, effective January 1, 2019, for the cut-off of the ongoing and unearned premium of AmTrust's Small Commercial Business and US Extended Warranty and Specialty Risk as of December 31, 2018, with the remainder of the Maiden Quota Share Agreement remaining in place. The amendment will result in Maiden returning approximately $700M in gross unearned premium to AmTrust, which will net to approximately $480M after consideration of ceding commission and brokerage.

10:23 EDT Nissan reports December U.S. sales up 7.6% to 148,720 vehicles - Nissan Group announced total U.S. sales for December 2018 of 148,720 units, an increase of 7.6% versus the prior year. Nissan Group also announced total calendar year 2018 U.S. sales of 1,493,877 units, a decrease of 6.2% compared to the prior year.

10:15 EDT PNC Financial expands board of directors to 14 from 11 - The PNC Financial Services Group (PNC) increased the number of directors on its board to 14 and appointed three new members. Joseph Alvarado, Richard Harshman and Toni Townes-Whitley will join PNC's board, effective immediately. Alvarado is the former chairman, president and CEO of Commercial Metals Company (CMC). Harshman is the current chairman and former president and CEO of Allegheny Technologies (ATI). Townes-Whitley is president, U.S. regulated industries at Microsoft (MSFT).

10:05 EDT Ford sees total December industry SAAR in mid- to high-17M vehicle range - Sees total December industry sales "strong," with 1.62M-1.65M vehicles sold. Sees total December industry SAAR in the mid- to high-17M vehicle range. Sees sales 17.6M vehicles for 2018, but may end up "slightly ahead" of last year's numbers. Comments taken from Ford's December U.S. sales conference call. Shares of Ford are down fractionally to $7.89 in morning trading.

10:04 EDT Corbus announces collaboration with Kaken to commercialize Lenabasum in Japan - Corbus Pharmaceuticals announced that they have entered into a strategic collaboration with Kaken Pharmaceutical Co. for the development and commercialization in Japan of Corbus' investigational drug lenabasum for the treatment of systemic sclerosis and dermatomyositis, two rare and serious autoimmune diseases. Under the terms of the agreement, Kaken receives an exclusive license to commercialize and market lenabasum in Japan for systemic sclerosis and dermatomyositis. Kaken will make an upfront payment to Corbus of $27M. Corbus will be eligible to receive in addition up to $173M upon achievement of certain regulatory, development and sales milestones as well as double-digit royalties. Current patient numbers for systemic sclerosis and dermatomyositis1 in Japan are 28,000 and 9,000, respectively, according to the companies. Yuval Cohen, PhD., CEO of Corbus, said, "Kaken is a well-regarded leader in rare autoimmune diseases in Japan with a proud history of scientific and medical innovation. By working together, we believe we can expand the Japanese footprint for lenabasum alongside Corbus' ongoing efforts in the U.S. and E.U. This collaboration is an important next step in achieving our vision of becoming the global leader in treating inflammatory diseases by focusing on the endocannabinoid system."

10:01 EDT Trump says U.S. getting 'MANY' billions in tariffs after Apple issues warning - When lowering his company's sales outlook for the first quarter, Apple CEO Tim Cook said last night, "We believe the economic environment in China has been further impacted by rising trade tensions with the United States." President Donald Trump weighed in this morning by tweeting, "The United States Treasury has taken in MANY billions of dollars from the Tariffs we are charging China and other countries that have not treated us fairly. In the meantime we are doing well in various Trade Negotiations currently going on. At some point this had to be done!"

10:00 EDT STMicroelectronics falls -9.4% - STMicroelectronics is down -9.4%, or -$1.29 to $12.45.

10:00 EDT Centrais Electricas rises 8.6% - Centrais Electricas is up 8.6%, or 65c to $8.20.

10:00 EDT Park Electrochemical rises 14.1% - Park Electrochemical is up 14.1%, or $2.59 to $21.01.

09:47 EDT Pyxus falls -4.9% - Pyxus is down -4.9%, or -62c to $12.03.

09:47 EDT Bristol-Myers falls -10.4% - Bristol-Myers is down -10.4%, or -$5.42 to $46.60.

09:47 EDT Sabesp rises 14.3% - Sabesp is up 14.3%, or $1.29 to $10.33.

09:46 EDT Ford reports December U.S. sales down 8.8% to 220,774 vehicles - "Ford sold more than 900,000 F - Series trucks in 2018 to extend our leadership position to 42 consecutive years as America's best - selling pickup; our commercial vans mark 40 straight years of leadership and we had a record year for Ford SUVs, all of which helped us post our ninth straight year as America's best - selling brand," said Mark LaNeve, Ford vice president, U.S. Marketing, Sales and Service

09:29 EDT Merit Medical increases board to 11 directors from nine - Merit Medical announced that its board increased the number of directors of the company from nine to 11 and elected Jill Anderson and Elizabeth Huebner to fill the new board positions. Anderson co-founded Cianna Medical in 2008 and served as CEO until Merit acquired Cianna in November 2018. Huebner served as a director of Blucora, a financial technology company focused on providing online tax preparation and wealth management products, where she served as chair of the audit and nominating & corporate governance committees and a member of the compensation committee.

09:23 EDT Toyota Motor NA reports December U.S. sales of 220,910 units, down 0.9% - Toyota Motor North America reported December 2018 sales of 220,910 vehicles, a decrease of 0.9% from December 2017 on a volume basis. With the same number of selling days in December 2018 compared to December 2017, sales were down 0.9% on a daily selling rate basis. For the year, TMNA reported sales of 2,426,672 vehicles, a 0.3% decrease on a volume basis and down 0.6% on a DSR basis. Toyota division posted December sales of 185,386 units, down 1.1% on a volume and DSR basis. For the year, Toyota division reported sales of 2,128,362 vehicles, flat on a volume basis and down 0.4% on a DSR basis.

09:19 EDT Diffusion Pharmaceuticals regains compliance with Nasdaq - Diffusion Pharmaceuticals announced it received notice from Nasdaq staff that the company has regained compliance with Listing Rule 5550 and will remain listed on the Nasdaq stock market. The news came as a result of the closing bid price of Diffusion's stock remaining above $1.00 per share between December 14 and December 28, 2018.

09:17 EDT Avalon GloboCare announces joint venture with Arbele Limited - Avalon GloboCare announced that the company and its wholly owned subsidiary, Avactis Biosciences, have entered into a joint venture and exclusive license agreement with Arbele Limited to co-develop transposon-based Chimeric Antigen Receptor, or CAR-T, and CAR-Natural Killer, or NK, cellular therapies. These CAR vector constructs are non-virally engineered, possessing multiple therapeutic targets as well as "safety-switch" mechanisms. Based on Avalon's hospital network for cellular therapy, together with the company's GMP bio-production facility in China, this joint venture allows Avalon to accelerate the clinical development of more efficacious and safer CAR-T/CAR-NK therapies, such as those developed by Arbele.

09:14 EDT Cerner partners with CoverMyMeds for prescription price transparency - Cerne has collaborated with CoverMyMeds to integrate patient-specific information into the electronic health record, or EHR, for providers to review prescription pricing information with their patients at the point of care. Prescription price transparency can help simplify conversations between individuals and their providers to create care plans that meet medical and financial needs. When implemented, providers will be able to view prescription benefit information in the EHR before medication is prescribed. Integrating CoverMyMeds' RxBenefit Clarity solution into the Cerner ePrescribe workflow will leverage additional information from industry stakeholders that was not previously available.

09:12 EDT MicroVision raises $1.2M from common stock sale - MicroVision announced the sale of 2M shares of its common stock at a price of 60c per share to Shehnee Lawrence-Farhi in a registered direct offering for gross proceeds of $1.2M. MicroVision intends to use the net proceeds for general corporate purposes.

09:08 EDT Delta Air Lines sees Q4 system capacity growth of 4% y/y - Sees Q4 adjusted TRASM up approximately 3% y/y. Sees Q4 CASM-ex down about 0.5% y/y.

09:06 EDT Delta Air Lines sees Q4 adjusted pre-tax margin 10%-11% - Above prior year result of 9.8%

09:06 EDT Overstock.com to pay Ohio state business taxes in Bitcoin - Overstock.com announced that it will become the first major U.S. company to pay a portion of its Ohio state business taxes in bitcoin using the state's new cryptocurrency taxpayer platform, OhioCrypto.com. Overstock plans to pay its commercial activity taxes in Ohio this February using the recently-launched OhioCrypto.com platform, which allows taxpayers to pay state business taxes with bitcoin. Ohio is the first U.S. state to offer a cryptocurrency payment system for state business taxes."We have long thought that thoughtful governmental adoption of emerging technologies such as cryptocurrencies is the best way to ensure the U.S. does not lose our place at the forefront of the ever-advancing global economy," said Overstock CEO and founder Patrick M. Byrne. "We are proud to partner with forward-thinking governments and officials like Ohio and Treasurer Mandel to help usher in an era of trust through technology for our nation's essential financial systems."

09:02 EDT Delta Air Lines reports December traffic up 5.4%, capacity up 5.4% - Reports December load factor 84.2%, flat vs. a year ago.

09:00 EDT Qualcomm posts bonds to enforce permanent injunction against iPhones in Germany - Qualcomm (QCOM) announced that it has posted security bonds totaling EUR1.34B. The bonds are required for Qualcomm to be able to enforce the remedies ordered by the Court on December 20, 2018, after the Court found that Apple (AAPL) is infringing Qualcomm's patented power savings technology used in smartphones. Apple was ordered to cease the sale, offer for sale and importation for sale of all infringing iPhones in Germany. The Court also ordered Apple to recall infringing iPhones from third party re-sellers in Germany.

08:49 EDT MGM Resorts to enter New York and Ohio markets - Jim Murren, Chairman and CEO said, "We had a solid finish to the year in 2018, and as we look to 2019 and beyond, we remain confident in the ramp of our newly opened properties MGM COTAI, MGM Springfield, Park MGM and NoMad Las Vegas. We will enter two attractive markets in New York and Ohio. We will continue to work toward cementing MGM Resorts as the leader in sports, following the milestones achieved in 2018 with GVC and the professional sports leagues. We remain focused on pursuing an integrated resort opportunity in Japan. MGM 2020 reinforces our commitment to increasing margins and maximizing profitability."

08:45 EDT Bristol-Myers says not providing long-term guidance at this time

08:44 EDT Cosan announces final results of $100M tender offer - Cosan announced the final results of its tender offer to purchase up to $100M of its Class A common shares, or the shares, at (i) prices specified by the tendering shareholders of not greater than $9.30 nor less than $8.88 per share or (ii) at the purchase price determined in accordance with the tender offer. The tender offer expired at 11:59 p.m., New York City time, on December 28, 2018. Based on the final count by Computershare Trust Company, N.A., the Depositary for the tender offer, a total of 30,871,499 Class A common shares of Cosan were properly tendered and not properly withdrawn at the final cash purchase price of $8.88 per share. Because the tender offer was oversubscribed, the company purchased only a prorated portion of the shares properly tendered by each tendering shareholder at the final per share cash purchase price of $8.88. Based on the final tender count, and taking into consideration the effect of odd lot priority and conditional tenders on the proration factor, the final proration factor for the tender offer was 49.74% of the shares properly tendered at the cash purchase price of $8.88 per share. Accordingly, Cosan acquired 14,228,134 shares at a purchase price of $8.88 per share, for a total cost of approximately $126.3M, excluding fees and other expenses related to the tender offer. These shares represent 9.6% of the issued and outstanding Class A common shares of Cosan as of December 31, 2018. The shares accepted for purchase include 2,966,873 additional shares that Cosan has elected to purchase pursuant to its right to purchase up to an additional 2% of its outstanding Class A common shares.

08:40 EDT InflaRx opens new corporate office in New York City - InflaRx announced the opening of the company's second U.S.-based location and the addition of new management members. The new corporate office follows the opening of the company's R&D facility in Ann Arbor, Michigan in June 2018. The new facility will be part of InflaRx Pharmaceuticals, a wholly owned subsidiary of the InflaRx.

08:38 EDT Heron Therapeutics' HTX-011 enables 90% avoidance of opioids in hernia surgery - Heron Therapeutics announced results of a multi-center postoperative pain management study in which 63 patients undergoing hernia repair surgery received the investigational agent, HTX-011, together with a regimen of generic over-the-counter oral analgesics, acetaminophen and ibuprofen. 90% of patients receiving HTX-011 with the OTC analgesic regimen did not require opioids to manage their postoperative pain through 72 hours post-surgery, compared to 51%, 40% and 22% of patients receiving HTX-011, bupivacaine and placebo, respectively, in the prior Phase 3 study. 81% of patients receiving HTX-011 with the OTC analgesic regimen remained opioid-free through 28 days post-surgery. Over 72 hours post-surgery, patients receiving HTX-011 plus the OTC analgesic regimen consumed an average of 0.9 morphine milligram equivalents, which compares to 10.8 MME, 14.5 MME and 17.5 MME for patients receiving HTX-011, bupivacaine and placebo, respectively, in the prior Phase 3 study. Heron submitted a New Drug Application to the FDA for HTX-011 in October of 2018 and received Priority Review designation in December of 2018. The FDA set a Prescription Drug User Fee Act goal date of April 30.

08:37 EDT BioXcel Therapeutics dexmedetomidine trial meets primary endpoint - BioXcel Therapeutics announced proof-of-concept data from its Phase 1 study of IV dexmedetomidine, or Dex, for acute treatment of agitation in patients with Senile Dementia of the Alzheimer's Type, or SDAT. The positive data from this Phase 1 trial provides evidence to support the continued clinical development of BXCL501 for the acute treatment of agitation under the accelerated fast track regulatory process. Agitation is common across all severities of Alzheimer's Disease, with an increasing prevalence as the disease progresses. The SDAT trial met its primary endpoint by identifying a safe dose of IV Dex that produced a mild arousable sedation, defined by a RASS2 score of -1. Data from this study, along with data from previously completed Phase 1 studies of IV Dex in agitated patients with schizophrenia and healthy elderly volunteers, is valuable in determining the optimal dose of BXCL501, a sublingual thin film formulation of Dex, being developed for the acute treatment of agitation. This study enrolled a total of 14 SDAT patients. Ten patients in the treatment arm received IV Dex therapy, while 4 patients received placebo. In accordance with study designs used in previous participant populations, Dex treatment was begun at 0.1 mcg/kg/h and dose escalation occurred every 30 minutes by increasing the infusion rate by 0.1 mcg/kg/h to a maximum infusion of 0.5 mcg/kg/h. Such dosing allowed for the efficient determination of the optimal dose in each participant. The study demonstrated that seven out of 10 patients in the treatment arm achieved arousable sedation, with only 1 of 4 patients in the placebo arm. The drug was well tolerated without any clinically significant adverse events.

08:36 EDT Mellanox names Doug Ahrens as CFO - Mellanox Technologies announced the appointment of Doug Ahrens as SVP and CFO, effective January 2, 2019. Ahrens will have overall responsibility for worldwide financial operations and strategy including planning and analysis, accounting, compliance, financial reporting and investor relations. Ahrens has extensive financial and operational experience in the technology industry, and joins Mellanox from GlobalLogic, where he served as CFO. Eric Johnson, who acted as Mellanox's interim principal financial and accounting officer, remains an integral part of the finance team and will continue in his role as VP and corporate controller.

08:34 EDT Immersion, Google enter into agreement to develop next-gen haptic devices - Immersion Corporation (IMMR) announced it has entered into a multi-year agreement with Google (GOOG, GOOGL) under which the companies will explore opportunities to collaborate on incorporating haptics in Google's next-generation hardware products. The agreement also provides Google with a license to Immersion's patent portfolio for Google's Pixel line of phones and other Google hardware. Other terms of the agreement are confidential .

08:33 EDT Cision acquires Falcon.io, terms not disclosed - Cision announced it has acquired Falcon.io, a leading social media company with offices in New York, Copenhagen, Sofia, Berlin, Melbourne and Budapest. Falcon.io provides brands with insights into their global content strategy and the management of comprehensive social media marketing programs through publishing, engagement, listening, advertising and measurement.

08:32 EDT Bristol-Myers says commitment to Opdivo 'strong'

08:28 EDT Jounce Therapeutics completes enrollment in first cohort of JTX-4014 trial - Jounce Therapeutics announced that the company completed enrollment in the first cohort for its Phase 1 dose escalation clinical trial of JTX-4014 as monotherapy in patients with solid tumors. JTX-4014 is a fully human IgG4 monoclonal antibody designed to specifically bind to PD-1 and block its interaction with its ligands, PD-L1 and PD-L2, to augment anti-tumor T cell activity. Jounce is developing JTX-4014 for potential use in combination with its pipeline of future product candidates.

08:27 EDT PRGX Global appoints Kurt Abkemeier as CFO - PRGX Global announced that the board has appointed Kurt Abkemeier as CFO, treasurer and controller, effective January 3. Peter Limeri, who has been serving as the interim CFO, treasurer and controller, will remain with the company until the end of the month. Abkemeier joins PRGX from Fidelis Cybersecurity where he served as CFO.

08:20 EDT EDAP TMS to sell first Focal One in U.S. to JWCI - EDAP TMS announced that the John Wayne Cancer Institute, or JWCI, at the Providence Saint John's Health Center in Santa Monica, California is the first medical center in the U.S. to offer focal therapy to patients with localized prostate cancer using Focal One, the most advanced technology available for delivering high intensity focused ultrasound to target and ablate diseased tissue. This initial sale into the U.S. market comes just six months after Focal One received 510 clearance from the FDA in June 2018.

08:17 EDT NextGen Healthcare announces partnership with Holon Solutions - NextGen Healthcare announced its partnership with healthcare information technology vendor Holon Solutions to deliver patient-centric population health insights at the point of care in a wide array of electronic health record, or EHR, solutions, without the need for conventional interfaces.

08:16 EDT General Motors announces appointment of Mark Reuss as company President - General Motors announced the appointment of Mark Reuss as company president, effective immediately. Reuss currently leads the Global Product Group and Cadillac and will now assume responsibility for the Quality organization.

08:14 EDT Honeywell announces $28M infrastructure project with Kunsan Air Base - Honeywell announced a $28M infrastructure modernization project with Kunsan Air Base, a U.S. Air Force Base located in South Korea. The project includes facility upgrades that aim to help improve infrastructure and equipment reliability while lowering the base's annual energy consumption by more than 18% and water consumption by over 7%. The project is expected to generate approximately $1.7M in annual energy savings. The project will be funded by a 25-year energy savings performance contract awarded to Honeywell by Kunsan AB, the Air Force Civil Engineer Center and Defense Logistics Agency-Energy. The contract enables the funding of the upgrades with annual energy and operational savings resulting from the project work. Honeywell guarantees the savings, eliminating the need for upfront capital investment and making it a self-funding project over the contract term.

08:11 EDT The Green Organic Dutchman signs sublicense with EnWave, Tilray - The Green Organic Dutchman is pleased to announce it has signed a royalty-bearing commercial sublicense with EnWave and Tilray. EnWave and Tilray entered into an exclusive partnership in October 2017 in which EnWave named Tilray as its licensed partner. The License grants Tilray an exclusive right to use and sub-license EnWave's proprietary REV dehydration technology in Canada. Under the terms of the License, EnWave and Tilray will share royalties from TGOD's use of EnWave's REV technology on an undisclosed basis. The Agreement grants TGOD the right to use EnWave's proprietary Radiant Energy Vacuum dehydration technology to dry organic cannabis in its Canadian operations. Pursuant to the Agreement, TGOD has signed an equipment purchase agreement and submitted a purchase order to EnWave for a large-scale 60kW commercial REV machine to initiate commercial production.

08:09 EDT UniFirst announces $100M share repurchase program - UniFirst's board approved a share repurchase program authorizing the company to repurchase up to $100M of its outstanding shares of common stock. Repurchases made under the program, if any, will be made in either the open market or in privately negotiated transactions. The timing, manner, price and amount of any repurchases will depend on a variety of factors and may be suspended or discontinued at any time.

08:08 EDT Enanta expects topline Phase 2 RSV challenge study data in mid-2019 - Enanta Pharmaceuticals announced that CEO Jay Luly will provide an update on its research and development programs in respiratory syncytial virus, hepatitis B virus and non-alcoholic steatohepatitis/primary biliary cholangitis, and discuss its business outlook for 2019 during Enanta's presentation at the 37th Annual J.P. Morgan Healthcare Conference on January 7, 2019 at 4:30 p.m. Pacific time. The following are details of Enanta's research and development program updates and expectations for 2019. EDP-938, N-Protein Inhibitor for Respiratory Syncytial Virus: Dosing is ongoing in a Phase 2a human challenge study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of EDP-938 orally administered to healthy subjects infected with a strain of respiratory syncytial virus. The trial is advancing well, and topline data is now expected mid-2019. EDP-514, Core Inhibitor for Hepatitis B Virus: Pre-clinical data on EDP-514, a promising inhibitor of the HBV core protein, will be presented during the formal presentation on January 7. Data presented on EDP-514 will demonstrate potent inhibition of HBV replication in vitro accompanied by a greater than 4-log viral load reduction in vivo. A Phase 1 study of EDP-514, is planned to begin in the second half of 2019. The study will evaluate single and multiple doses of drug in healthy volunteers and will incorporate a Phase 1b arm in patients with chronic HBV infection. EDP-305, FXR agonist for NASH: Enrollment in the 12-week Phase 2a NASH trial is expected to conclude in the first quarter of 2019 allowing Enanta to report preliminary top line data in the third quarter of 2019. Enanta also expects to identify an FXR follow-on clinical candidate in 2019.

08:06 EDT MySize launches MySizeID smart measurement fashion app for Android - MySize (MYSZ) announced the launch of its MySizeID smart measurement technology for Android (GOOG, GOOGL) on December 31, 2018. The newly released consumer fashion app, already available for iOS (AAPL), can be downloaded for Android in the Google Play Store. My Size will showcase the Android version of MySizeID for the first time at NRF 2019 at its booth (#7000) at The Javits Center in New York City from January 13-15, 2019.

08:04 EDT Vertex, Arbor Biotechnologies enter collaboration for novel proteins - Vertex Pharmaceuticals and Arbor Biotechnologies announced that the two companies have entered into a strategic research collaboration focused on the discovery of novel proteins including DNA endonucleases to advance the development of new gene-editing therapies for cystic fibrosis and four other diseases to be selected later. Arbor has developed a protein biodiscovery platform that includes a comprehensive set of technologies and techniques, integrating machine learning, genome sequencing, gene synthesis, and high-throughput screening that will augment Vertex's efforts to develop gene-editing approaches for the treatment of serious diseases. Under the terms of the collaboration, scientists from Vertex and Arbor will work closely together to discover novel proteins and tools that Vertex may use in the development of new medicines. The focus of the collaboration is to discover novel programmable DNA endonucleases or nickases with high fidelity and catalytic activity as well as novel transduction approaches. Discovery activities will be conducted primarily by Arbor and funded by Vertex. Vertex will provide Arbor with an up-front cash commitment, fund research activities, and will pay research, development, regulatory, and commercial milestones, as well as royalties on future net sales. Vertex will also make an investment in Arbor in the form of a convertible note and obtain an observer seat on the Arbor Board of Directors.

08:03 EDT Audentes Therapeutics appoints Eric Mosbrooker as Chief Commercial Officer - Audentes Therapeutics has appointed Eric B. Mosbrooker as Senior VP and Chief Commercial Officer. Mosbrooker joins Audentes from Origin Biosciences, a subsidiary of BridgeBio Pharma and a biotechnology company, where he served as Chief Operating Officer. Prior to Origin Biosciences, Mosbrooker led the orphan business at Horizon Pharma after its acquisition of Raptor Pharmaceuticals. At Raptor, he was the Senior Vice President of Americas & Asia Pacific.

07:47 EDT General Motors reports Q4 total deliveries down 2.7% to 785,229 vehicles - General Motors announced that it delivered 2,954,037 vehicles in 2018, including more than 1 million crossovers, almost 974,000 pickup trucks and more than 280,000 large SUVs. GM's fourth quarter deliveries totaled 785,229 units, down 2.7% y/y, and the company's share of the industry's retail sales grew every month from October through December. GM crossover deliveries totaled 1,034,808 in 2018, up 7 percent versus 2017. Total sales of all utility vehicles, including large SUVs, totaled 1,295,700, up 7 percent. The Chevrolet Tahoe and Suburban were up 5 percent and 7 percent, respectively, and the Cadillac Escalade ended the year with a retail segment share twice that of its closest domestic competitor. "We are very bullish on pickups heading into 2019," the company said. GM estimates that the light vehicle SAAR in the fourth quarter was 17.7 million units. Light vehicle sales for the calendar year are estimated at 17.3 million units. GM's retail mix was 80 percent for the fourth quarter and 79 percent for the year. ATPs were a record $36,974 in the fourth quarter and a record $35,839 for the year, according to J.D. Power PIN estimates.

07:47 EDT Allergan announces new pharmacology research for rapastinel - Allergan announced new pharmacology research for its investigational compound rapastinel, which is currently being studied in Phase 3 trials for the treatment of major depressive disorder. Published in the International Journal of Neuropsychopharmacology, the preclinical research supports that rapastinel exhibited rapid and sustained antidepressant effects through positive modulation of the NMDA receptor and suggests that it may work differently from NMDA receptor antagonists like ketamine and S-ketamine.

07:41 EDT Otonomy sees sufficient funding through 2020 - Otonomy expects that its current cash, cash equivalents, and short term investments will be sufficient to fund the company through completion of the OTIVIDEX Phase 3 trial, OTO-313 Phase 1/2 trial, and OTO-413 Phase 1/2 trial in 2020, and will support company operations into 2021.

07:38 EDT Moleculin Biotech announces preliminary WP1732 data - Moleculin Biotech announced that in preliminary animal studies, a second of its lead drugs, WP1732, has demonstrated enhanced activity in combination with checkpoint blockade antibodies in pancreatic cancer. "After our sponsored research demonstrated that WP1066 was able to enhance immune checkpoint activity in a pancreatic cancer animal model," commented Walter Klemp, Moleculin's chairman and CEO. "We were optimistic that we could show similar potential results in our water soluble, WP1732 drug candidate. This is significant for several reasons. It shows that this is a consistent capability across our platform of STAT3 inhibitors and it further supports independent research suggesting that STAT3 may be a key to enabling checkpoint blockade activity in otherwise resistant tumors. Importantly, though, when you couple this with our recent findings that WP1732 accumulates disproportionately in the pancreas, we believe it points to WP1732 as a potentially pivotal new approach to treating pancreatic cancer. Expansion of the WP1732 and WP1066 in vivo studies is in progress."

07:36 EDT CME Group reports 2018 average daily volume up 18% to 19.2M contracts - CME Group reported 2018 average daily volume reached a record 19.2 million contracts, up 18% from 2017. During 2018, 91 trading days exceeded 20 million contracts, up from 34 days in 2017. Record Interest Rate ADV was up 22% to 9.95 million contracts; record Metals ADV was up 12% to 638,000 contracts; record FX ADV was up 9% to 1 million contracts; record full-year 2018 options ADV was up 14% to 3.9 million contracts, including record electronic options ADV, up 20% to 2.6 million contracts. Q4 volume averaged 20.8 million contracts per day, up 31% from the same period a year ago. December 2018 volume averaged 20.2 contracts per day, up 36% from December 2017. Open interest at the end of December was 116 million contracts, up 7% from the end of December 2017. Equity Index volume averaged a record 5.1 million contracts per day in December 2018, up 73% from December 2017.

07:33 EDT Deciphera initiates Phase 1b/2 trial of rebastinib, carboplatin combination - Deciphera Pharmaceuticals announced that it has initiated an open-label, multicenter, Phase 1b/2 study of rebastinib, the Company's investigational small molecule switch control inhibitor of TIE2 kinase, in combination with carboplatin in patients with advanced or metastatic solid tumors. Part 1 of this two part study is designed to evaluate the safety, tolerability and pharmacokinetics of 50 mg and 100 mg rebastinib twice daily when administered in combination with carboplatin, and to determine the recommended phase 2 dose of rebastinib in combination with carboplatin, in patients with advanced or metastatic solid tumors that are refractory to standard therapies. In part 2, the safety, tolerability and efficacy of the RP2D of rebastinib in combination with carboplatin administered once every 3 weeks will be assessed across multiple disease cohorts, including: breast cancer, ovarian cancer, and mesothelioma. This trial is expected to enroll up to 117 patients in total, with approximately 18 patients in part 1 and up to 99 patients in part 2.

07:24 EDT Charlotte's Web names former Coca-Cola exec. Eugenio Mendez as CGO - Charlotte's Web Holdings (CWBHF), which engages in in whole-plant hemp extract products with naturally occurring cannabidiol, announces that Eugenio Mendez has joined the company in the newly formed role of Chief Growth Officer effective January 15, 2019. Mendez comes to Charlotte's Web from the Coca-Cola Company (KO), where he served as Vice-President, Global Marketing of Water, Enhanced Water and Sport Drinks. Mendez led global strategy and marketing for the division which has annual sales of $12B. Mr. Mendez has also served in an advisory role to Charlotte's Web for nearly two years. As the company's Chief Growth Officer, he will lead the company's business development, marketing and sales functions. The new leadership addition is the first of several appointments that will be made in 2019 to support Charlotte's Web's growth and evolution to a global CPG retail brand. A CEO transition is planned in 2019 to support the company's continued evolution.

07:19 EDT Shire: Court sanctions scheme of arrangement for Takeda deal - Shire (SHPG) announced that the Royal Court of Jersey has sanctioned the scheme of arrangement pursuant to Article 125 of the Companies Law 1991 by which the recommended cash and share offer made by Takeda Pharmaceutical Company Limited (TKPYY) for the entire issued and to be issued share capital of Shire is being implemented. The Scheme will become effective upon a copy of the Court order being delivered to the registrar of companies in Jersey, which is expected to take place on January 8, 2019. The Scheme will become effective upon a copy of the Court order being delivered to the registrar of companies in Jersey, which is expected to take place on January 8, 2019.

07:16 EDT Bristol-Myers down 14% to $44.98 after agreeing to acquire Celgene - Celgene is up 30% to $87.04 in pre-market trading.

07:12 EDT Amicus initiates gene therapy study for CLN3 Batten disease - Amicus announced the initiation of a Phase 1/2 clinical study to evaluate the safety and efficacy of a single intrathecal administration of adeno-associated virus serotype 9 AAV9-CLN3 gene therapy in children with CLN3 Batten disease. Batten disease is the common name for a broad class of rare, fatal, inherited disorders of the nervous system also known as neuronal ceroid lipofuscinoses, or NCLs. The initial patient completed a one-month observation period following dosing with no serious adverse events reported to date. This first in human study of an investigational gene therapy in CLN3 Batten disease, a life-threatening genetic neurologic disorder that typically begins in early childhood and results in premature death, is currently being conducted at Nationwide Children's Hospital. CLN3 is the most prevalent of the Batten's disorders affecting an estimated 5,000+ patients. The Phase 1/2 study is enrolling children aged 3 to 10 years with a confirmed diagnosis of CLN3 Batten disease in two sequential intrathecal dose groups: a one-time low-dose of AAV9-CLN3 and a one-time high-dose of AAV9-CLN3 after evaluation of Group 1 participants. Both groups will participate in the current study for a period of three years. Amicus plans to present clinical data from this study, including interim data, at future scientific congresses and other relevant venues. The primary outcome measures are safety and efficacy as determined using the physical disability subscale of the Unified Batten Disease Rating Scale in CLN3 Batten disease.

07:09 EDT Canadian Solar providing EPC services and solar modules to Australian solar farm - Canadian Solar will be partnering with Signal Energy to provide Engineering, Procurement and Constructions services and supply solar modules for ESCO Pacific's 175MWp/133MWac Finley Solar Farm in New South Wales, Australia. Over 490,000 of Canadian Solar's 1500V KuMax modules will be installed on single-axis solar tracking systems.

07:08 EDT Veracyte, Johnson & Johnson Innovation enter collaboration for lung cancer tests - Veracyte (VCYT) announced that it has entered into a long-term strategic collaboration with Johnson & Johnson Innovation (JNJ) and the Lung Cancer Initiative at Johnson & Johnson to advance the development and commercialization of novel diagnostic tests to detect lung cancer at its earliest stages, when the disease is most treatable. The collaboration will build upon foundational "field of injury" science -- where genomic changes associated with lung cancer can be identified with a simple brushing of a person's airway -- to develop new interventions that can save lives. Under terms of the agreement, Veracyte and the Lung Cancer Initiative at Johnson & Johnson, whose mission is to prevent, intercept and cure lung cancer, will combine clinical study cohorts involving more than 5,000 patients with multiple years of clinical outcome data. Veracyte will contribute bronchial and nasal samples from its clinical trials, which are part of the company's extensive lung cancer-focused biorepository. Veracyte will deploy its RNA whole-transcriptome sequencing platform, utilizing high-dimensional data and machine learning pipelines on the combined cohort, providing the most comprehensive genomic content available which the Lung Cancer Initiative at Johnson & Johnson will have access to for therapeutic purposes. The collaboration is expected to accelerate two key lung cancer programs for Veracyte. First, the development of the first non-invasive nasal swab test for early lung cancer detection and, secondly, the commercialization of its Percepta classifier on the company's RNA whole-transcriptome sequencing platform, which, as a result of this collaboration, is expected to launch in 1H19. "We are thrilled to team up with Johnson & Johnson and their Lung Cancer Initiative in the fight against lung cancer," said Bonnie Anderson, Veracyte CEO. "This strategic collaboration further advances Veracyte's pioneering position in lung cancer diagnosis and underscores the promise of our field of injury science and approach. With the acceleration of our product pipeline, we believe this collaboration expands our addressable lung cancer diagnostic market to a $30B to $40B global opportunity. We estimate the combined monetary and non-monetary value of the collaboration to Veracyte at more than $50M. The monetary component consists of a $5M upfront payment and the potential to earn up to a total of $15M in future development and reimbursement milestone payments. The non-monetary value reflects the significant value of clinical cohorts accessible to Veracyte through the collaboration. Also as result of this agreement, we expect our biopharmaceutical service revenue for 2019 to increase by an estimated $5M."

07:06 EDT Incyte appoints Christiana Stamoulis as CFO - Incyte (INCY) announced the appointment of Christiana Stamoulis as Executive Vice President and CFO, effective February 11. Stamoulis will succeed David Gryska who, as planned, retired from Incyte at the end of 2018. She joins Incyte from Unum Therapeutics (UMRX), where she was President and CFO.

07:06 EDT Athenex announces license agreement, partnership with Chongqing Jingdong - Athenex announced that, through its subsidiary, it has entered into a licensing and partnership agreement with Chongqing Jingdong Junzhuo Pharmaceutical to exclusively develop and commercialize KX2-391 for the treatment of actinic keratosis and oncology indications in humans in China. KX2-391, also known as KX-01, is a first-in-class dual Src kinase and tubulin polymerization inhibitor. KX2-391 ointment is a topical medicinal product for the treatment of actinic keratosis that is in late stage Phase III development. Actinic keratosis is a common skin condition that is induced through ultra-violet light damage, resulting in patches of thick, scaly, or crusty skin. Left untreated, the lesions have risk of progression to squamous cell carcinoma and, consequently, treatment by a dermatologist is recommended. Other drug candidates with KX2-391 as the active ingredient are also being developed for oncology indications. Pursuant to the terms and conditions of the arrangement, Athenex will grant to Chongqing Jingdong Pharmaceutical an exclusive license under Athenex's intellectual property to commercialize topical and oral products containing KX2-391 in mainland China, excluding Hong Kong, Macau and Taiwan. Athenex is expected to receive an upfront payment of an aggregate amount of $14.5M. Athenex will also be eligible to receive other development milestone payments of up to $15M. In addition, the agreement provides for tiered royalties based on annual net sales starting at 15% and with incremental increases of royalties with increases in sales. Athenex will be responsible for conducting all preclinical and clinical studies, as well as regulatory submissions, required for approval in China. Chongqing Jingdong Pharmaceutical will employ its expertise to plan and prepare for the commercialization of the products in China. Athenex announced on July 26, 2018 that statistical significance was achieved in two Phase III studies conducted in the United States to support the registration of KX2-391 ointment for the treatment of actinic keratosis. Athenex has submitted an abstract to the American Academy of Dermatology for potential presentation of top-line data from Phase III studies at the AAD meeting in March.

07:06 EDT comScore expands currency relationship with Gray Television - Comscore will serve as the local linear currency for the entire legacy Gray Television market footprint as well as the majority of Raycom's legacy footprint, including two of its largest markets, Cleveland and Louisville. Gray now owns and/or operates television stations in 91 markets across the country, and Comscore is now the exclusive ratings currency for 80 of these markets.

07:05 EDT Seres Therapeutics initiates SER-287 Phase 2B ECO-RESET clinical study - Seres Therapeutics announced that it has enrolled the first patient in its Phase 2B trial, ECO-RESET, evaluating microbiome development candidate SER-287 in patients with active mild-to-moderate ulcerative colitis. Seres has received $40M in milestone payments associated with this study start from Nestle Health Science. The SER-287 Phase 2B ECO-RESET study has been designed as a pivotal trial. The company recently obtained feedback from the FDA indicating that results from this study, in conjunction with data from a second pivotal study, could enable a SER-287 Biologics License Application. The Phase 2B study is a three-arm placebo-controlled trial of approximately 200 patients with active mild-to-moderate ulcerative colitis. Two groups of patients will receive different doses of SER-287, both following pretreatment with a short course of oral vancomycin. A third study arm will receive placebo. The study's primary endpoint will evaluate clinical remission measured after 10 weeks of SER-287 administration. Endoscopic improvement will be measured as a secondary efficacy measure.

07:03 EDT Ceva's RivieraWaves Bluetooth IP licensed by Bestechnic for audio platforms - CEVA's RivieraWaves Bluetooth IP has been licensed and deployed by Bestechnic, a designer and supplier of advanced audio platform SoCs, in its latest solution targeting high-end headphones and headsets.

07:03 EDT Celgene shareholders to receive 1 Bristol-Myers share, $50.00 in cash per share

07:03 EDT ImaginAb announces license, clinical trial collaboration with Nektar - ImaginAb announced that it has entered into a non-exclusive license and clinical trial collaboration with Nektar Therapeutics. Under the terms of the agreement, Nektar will use ImaginAb's CD8 ImmunoPET technology to measure whole body and tumor CD8+ T cells' density and distribution in cancer patients. The collaboration will provide important mechanistic insight into various candidates in Nektar's immuno-oncology portfolio. Financial terms of the agreement were not disclosed.

07:02 EDT Molina Healthcare renews agreement with CVS Caremark - Molina Healthcare (MOH) announced that, following a comprehensive procurement process, it has extended its agreement with CVS Caremark (CVS) for pharmacy benefit management, or PBM, services through 2021. Under the agreement, which became effective January 1, 2019, CVS Caremark will continue to administer pharmacy benefits for the approximately 4M members Molina serves through its Medicaid, Medicare, and Marketplace health plans. The extension modifies Molina's existing agreement with CVS Caremark to align Molina's pharmacy management strategy with the operational improvement initiatives that have been underway over the last year under its new management team. The agreement is immediately accretive to earnings and will enable Molina to remain responsive to state partner requirements as it manages its nearly $3B of annual pharmacy expenses in an evolving government-sponsored health care landscape. This PBM initiative is one of several that Molina has pursued to lower its costs, including clinical strategies with formulary, utilization management and generic dispensing initiatives, while improving health outcomes for members.

07:00 EDT Bristol-Myers to acquire Celgene in deal with equity value of approx. $74B - Bristol-Myers Squibb Company (BMY) and Celgene Corporation (CELG) announced that they have entered into a definitive merger agreement under which Bristol-Myers Squibb will acquire Celgene in a cash and stock transaction with an equity value of approximately $74 billion. Under the terms of the agreement, Celgene shareholders will receive 1.0 Bristol-Myers Squibb share and $50.00 in cash for each share of Celgene. Celgene shareholders will also receive one tradeable Contingent Value Right for each share of Celgene, which will entitle the holder to receive a payment for the achievement of future regulatory milestones. The Boards of Directors of both companies have approved the combination. Based on the closing price of Bristol-Myers Squibb stock of $52.43 on January 2, 2019, the cash and stock consideration to be received by Celgene shareholders at closing is valued at $102.43 per Celgene share and one CVR. When completed, Bristol-Myers Squibb shareholders are expected to own approximately 69 percent of the company, and Celgene shareholders are expected to own approximately 31 percent. The combined company will have nine products with more than $1 billion in annual sales and significant potential for growth in the core disease areas of oncology, immunology and inflammation and cardiovascular disease. Based on the closing price of Bristol-Myers Squibb stock on January 2, 2019, the cash and stock consideration to be received by Celgene shareholders is valued at $102.43 per share. The cash and stock consideration represents an approximately 51 percent premium to Celgene shareholders based on the 30-day volume weighted average closing stock price of Celgene prior to signing and an approximately 54 percent premium to Celgene shareholders based on the closing stock price of Celgene on January 2, 2019. The transaction is not subject to a financing condition. The cash portion will be funded through a combination of cash on hand and debt financing. Bristol-Myers Squibb has obtained fully committed debt financing from Morgan Stanley Senior Funding, Inc. and MUFG Bank, Ltd. Following the close of the transaction, Bristol-Myers Squibb expects that substantially all of the debt of the combined company will be pari passu.

06:57 EDT Computer Task Group to acquire Tech-IT PSF S.A. for about $10.3M in cash - CTG announced a definitive agreement to acquire Luxembourg-based Tech-IT PSF S.A., a leading consulting and IT solutions company, through its subsidiary CTG Luxembourg PSF S.A. The proposed all-cash transaction is valued at about $10.3M, not including potential future earn outs, for Tech-IT's estimated $20M in annualized revenue and approximately $1.5M of cash and cash equivalents. CTG expects to fund the $10.3M purchase price of the acquisition through a combination of cash on hand, and a drawdown of capital from the company's revolving credit facility. The boards of directors of both companies unanimously approved the transaction, which is subject to certain customary closing conditions, including regulatory approval from the Luxembourg regulatory entity and is anticipated to close in January 2019.

06:51 EDT Coca-Cola's proposed acquisition of Costa Coffee cleared by the EU - The European Commission has approved, under the EU Merger Regulation, the acquisition of Costa Coffee of the UK by The Coca Cola Company of the US. Costa Coffee operates coffee shops and hot beverage vending machines mainly in the UK, Ireland and Poland and sells packaged, roast and ground coffee and other ingredients. The Commission concluded that the proposed acquisition would raise no competition concerns because the companies do not sell the same products and the links between their activities are limited,

06:42 EDT Sesen Bio's bladder cancer candidate shows positive preliminary Phase 3 results - Sesen Bio reported 'positive' preliminary efficacy data for the primary endpoint of its ongoing Phase 3 registration trial, the VISTA Trial, of Vicinium for the treatment of patients with high-grade non-muscle invasive bladder cancer who have been previously treated with bacillus Calmette-Guerin and deemed BCG-unresponsive. The data reported show clinically meaningful complete response rates in evaluable Carcinoma in situ patients at three, six, nine and 12 months of follow-up in the trial consistent with the data in the completed Phase 1 and Phase 2 clinical trials. Vicinium continues to be generally well-tolerated in treated patients. The data reported build upon preliminary three-month data presented from a subset of patients in May 2018 and are for the primary endpoint of the VISTA Trial, which is the complete response rate and duration of response in patients in Cohort. The patient population in Cohort 3 represents an opportunity for future label expansion, and the company plans to report efficacy data from this cohort, as well as the secondary endpoints in the VISTA Trial, in mid-2019. As of the December 3, 2018 data cut off, in patients across all three cohorts, 78% of adverse events were Grade 1 or 2. Complete 12-month efficacy data from all patients in the clinical trial are expected to be reported at a medical meeting in mid-2019.

06:37 EDT Ohr Pharmaceutical announces merger agreement with NeuBase Therapeutics - Ohr Pharmaceutical announced that it has entered into a definitive merger agreement with NeuBase Therapeutics, under which the stockholders of NeuBase would become the majority holders of the combined company. The proposed merger will create a public company focused on advancing NeuBase's peptide-nucleic acid antisense oligonucleotide technology platform for the development of therapies to address severe and currently untreatable diseases caused by genetic mutations. Upon closing of the transaction, the combined company will change its name to "NeuBase Therapeutics, Inc." and propose its trading symbol on the NASDAQ be changed to "NBSE". The executive team of NeuBase will serve as the executive team of the combined company, led by Dietrich Stephan, Ph.D. as CEO. On a pro forma basis and based upon the number of shares of Ohr common stock to be issued in the merger, current Ohr stockholders will own approximately 20% of the combined company and NeuBase stockholders will own approximately 80% of the combined company, after accounting for the additional NeuBase financing transaction. The actual allocation will be subject to adjustment based on Ohr's and NeuBase's cash balance at the time of closing and the amount of the additional financing consummated by NeuBase at or before the closing of the merger. Certain members and affiliates of the board of directors and management of Ohr and Neubase have indicated an intent to invest in the additional NeuBase financing transaction. The proposed transaction has been approved by the board of directors of both companies. The merger is subject to the approval of Ohr shareholders at a special meeting of shareholders, which is expected to occur in the first half of 2019, along with the satisfaction or waiver of other customary conditions.

06:34 EDT UroGen Pharma appoints Elizabeth Barrett as CEO, replacing Ron Bentsur - UroGen Pharma (URGN) announced the appointment of Elizabeth Barrett as President and CEO effective immediately. She will also serve on the company's Board of Directors. Barrett, who will be based in New York, replaces Ron Bentsur. Bentsur will step down from his position at the company but will continue to serve in an advisory capacity as needed to ensure a smooth transition. . Barrett was CEO of Novartis Oncology and a member of the Executive Committee of Novartis (NVS). She previously served as Global President of Oncology at Pfizer (PFE).

06:32 EDT Trimble enters collaboration with Neurable - Neurable announced that it will collaborate with Trimble to bring brain-computer interface, or BCI, technology to innovative solutions in the transportation and architecture, engineering and construction, or AEC, industries. The two companies share a common vision of using neurotechnology to support digital transformation by providing a bi-directional feedback loop, driving increased safety and productivity. Neurable's technology can provide hands-free and voice-free interactions as well as cognitive analytics on behavior for insight-driven and data rich immersive experiences. Trimble and Neurable will leverage bio signals such as brain activity combined with eye tracking technology to improve training efficiency, driver safety and high-risk front-line worker safety as well as provide insights to augment the benefits of a simulation and design evaluation.

06:09 EDT MYOS receives patent for manufacturing process from USPTO - MYOS announced that it received the United States Patent 10,165,785 from the United States Patent and Trademark Office, or USPTO. This new patent enhances MYOS' existing intellectual property portfolio, enabling MYOS to protect its technologies for the development of nutrition products to address musculoskeletal health. The new patent covers a manufacturing process for a fertilized, egg yolk-derived composition that was developed by researchers at the German Institute of Food Technologies/DIL that helps maintain the natural bioactivity of egg yolk without compromising its safety. DIL has assigned full rights of this patent to MYOS.

06:02 EDT Ensign Group acquires Utah skilled nursing facility - Ensign Group acquired the real estate and operations of Bella Terra Cedar City, a skilled nursing facility with 120 skilled nursing beds located in Cedar City, Utah. Bella Terra had an occupancy rate of approximately 50% at the time of acquisition. This acquisition brings Ensign's portfolio to 189 skilled nursing operations

05:31 EDT AC Immune appoints Dr. Marie Kosco-Vilbois as Chief Scientific Officer - AC Immune announced that it has appointed Dr. Marie Kosco-Vilbois, as Chief Scientific Officer, effective January 3, 2019. Dr. Kosco-Vilbois has served as Chief Scientific Officer of Novimmune since 2005. In this position, Dr. Kosco-Vilbois will report directly to CEO Andrea Pfeifer. To facilitate her rapid integration into the Company she will be supported by Dr. David Lowe who has led AC Immune's Research ad interim and has held senior R&D roles in the Company since 2014.

05:29 EDT LabCorp signs licensing agreement with GENFIT, terms not disclosed - LabCorp and GENFIT have announced the signing of a licensing agreement between GENFIT and Covance, LabCorp's drug development business. The agreement will expand access to an innovative non-alcoholic steatohepatitis, or NASH, liver diagnostic test for the clinical research market. Financial terms for this agreement have not been disclosed.

05:20 EDT DBV names Hugh Sampson CMO, says Julie O'Neill to lead FDA resubmission - DBV Technologies (DBVT) announced that its Chief Scientific Officer, Dr. Hugh Sampson, will also assume the role of interim Chief Medical Officer effective today. Sampson succeeds Dr. Lucia Septien-Velez, who has decided to leave to pursue other opportunities. As CSO and interim CMO, Sampson will lead both the scientific and medical teams at the company and will report to Daniel Tasse, Chief Executive Officer of DBV Technologies. "Dr. Sampson is an accomplished leader and physician, and his research and scientific advancements have had a significant influence in the field of food allergies and immunology over the last 40 years," DBV said in a statement. Further, following recent interactions with the FDA, Julie O'Neill has been engaged effective immediately to direct all product development, manufacturing, supply chain, quality assurance, and end-to-end process optimization at the company. O'Neill was appointed to board in 2017 and will continue serving as a director while overseeing the anticipated resubmission of the Viaskin Peanut Biologics License Application in children four to 11 years of age. Most recently, she was Executive Vice President, Global Operations for Alexion Pharmaceuticals (ALXN). As part of the operational changes announced today, Alan Kerr, Senior Vice President, Head of Global Regulatory Affairs of DBV Technologies, will now report to the company's CEO, Daniel Tasse, effective immediately. Daniel Tasse stated: "These operational changes mark an important transition for DBV as we continue to evolve from late-stage research and development into a potentially commercial-stage company."