Stockwinners Market Radar for March 28, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:06 EDT Enbridge disappointed in Michigan AG position on Straits of Mackinac project - The company states: "After reviewing the statement issued by Michigan Attorney General Nessel and Governor Whitmer's executive directive, Enbridge is surprised and disappointed they have taken this position with respect to the legislation when the Straits tunnel project will further enhance the safety and reliability of a critical piece of infrastructure that supports the State, its communities and the environment. We intend to seek clarification from the Administration on a path forward. Line 5 will continue to safely operate, as it has for more than 60 years. Numerous independent reviews have concluded that the line is safe."

19:46 EDT AstraZeneca to pay Daiichi Sankyo up to $6.9B in DS-8201 commercialization pact - Daiichi Sankyo (DSNKY) announced that it has entered into a global development and commercialization agreement with AstraZeneca (AZN) for Daiichi Sankyo's lead antibody drug conjugate trastuzumab deruxtecan, or DS-8201, currently in pivotal development for multiple HER2 expressing cancers including breast and gastric cancer, and additional development in non-small cell lung and colorectal cancer. Daiichi Sankyo and AstraZeneca will jointly develop and commercialize trastuzumab deruxtecan as a monotherapy or a combination therapy worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and the supply of trastuzumab deruxtecan. Under the terms of the agreement, AstraZeneca will pay Daiichi Sankyo an upfront payment of $1.35B. Contingent payments of up to $5.55B include $3.8B for achievement of future regulatory milestones and other contingencies, as well as sales-related milestones of up to $1.75B. Total payments under the agreement have the potential to reach up to $6.90B. The impact on Daiichi Sankyo's consolidated results for the fiscal year ending March 31, 2019 is immaterial because the upfront payment will be booked in revenue over the period in which Daiichi Sankyo has contractual performance obligations under this collaboration. The collaboration is expected to contribute to enhancing the corporate and shareholder value of Daiichi Sankyo over the medium to long term.

18:48 EDT Broadridge CEO: Retail investors don't submit enough proxy votes - In an interview on CNBC's Mad Money, Broadridge CEO Richard Daly said: Companies will be more influenced the more retail investors vote... Institutional investors accounted for more than 99% of votes in proxy fights.

18:00 EDT Green Dot CEO sells 23.1K shares of common stock - In a regulatory filing, Greet Dot disclosed that its CEO Steven Streit sold 23.1K shares of common stock on March 26th-March 28th.

17:27 EDT First Bancshares authorizes $20M share repurchase plan - First Bancshares has authorized a new share repurchase program to purchase up to an aggregate of $20M of the company's common stock. The share repurchase program will have an expiration date of December 31.

17:15 EDT Revlon says ERP system disrupted ops, caused material weakness in reporting - In a 10-k filing, Revlon states: "Difficulties in implementing the company's new ERP system have disrupted the company's business operations and have caused a material weakness in the company's internal control over financial reporting. If the company is unable to remediate the material weakness in its internal control over financial reporting, it may negatively impact the Company's ability to prepare its future financial statements in conformity with U.S. GAAP. If the company experiences ongoing disruptions with such implementation and/or is unable to remediate the material weakness in the future, such events could have a material adverse effect on the company's business, prospects, results of operations, financial condition and/or cash flows."

17:10 EDT Gilead, Galapagos NV's Filgotinib meets endpoints in Phase 3 FINCH 1 RA study - Gilead (GILD) and Galapagos NV (GLPG) announced Week 24 results of FINCH 1, an ongoing, randomized, double-blind, placebo- and active-controlled Phase 3 study of filgotinib, an investigational, oral, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis. FINCH 1 evaluated filgotinib versus adalimumab or placebo, on a stable background dose of methotrexate in patients with prior inadequate response to methotrexate. The study achieved its primary endpoint for both doses of filgotinib in the proportion of patients achieving an American College of Rheumatology 20% response compared to placebo at Week 12. The proportion of patients achieving ACR50 and ACR70 response was also significantly greater for filgotinib compared with placebo at Week 12, for both doses. Patients receiving filgotinib 100 mg or 200 mg had a statistically significant reduction in the Health Assessment Questionnaire Disability Index at Week 12 compared with those receiving placebo. The proportions of patients achieving clinical remission and low disease activity less than or equal to 3.2) at Week 12 were significantly higher for patients in both filgotinib arms compared with placebo. When comparing low disease activity rates at Week 12, filgotinib 200 mg was non-inferior to adalimumab. Filgotinib 100 mg and 200 mg also significantly inhibited the progression of structural damage at Week 24 as assessed by change from baseline in modified total Sharp score compared with placebo.

17:06 EDT Gilead, Galapagos report updated Filgotinib safety information in RA - Gilead (GILD) and Galapagos NV (GLPG) announced interim safety information from four studies of the investigational compound filgotinib for the treatment of rheumatoid arthritis or RA. The data include 24 week results of the ongoing Phase 3 FINCH 1, 2, and 3 trials, and updated Week 156 safety data from the Phase 2b DARWIN 3 long term extension study in patients with RA. "The growing body of evidence from both the DARWIN 3 long-term extension trial combined with the results of the FINCH 1, 2, and 3 trials, represent a larger safety database in a broader population of RA patients, spanning from those who are treatment-naive to those who have failed biologics," said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead Sciences. "The available safety data from the FINCH and DARWIN 3 studies, which together included more than 2,700 patients receiving filgotinib, suggest that filgotinib has the potential to deliver a much needed option for treating people living with RA," said Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos. Filgotinib is an investigational agent and not approved anywhere globally. Its efficacy and safety have not been established.

17:05 EDT Straumann will pay Align $35M in pact to settle patent disputes - Align Technology and Straumann Group announced that they have reached an agreement to settle all currently outstanding patent disputes in the U.S., the U.K. and Brazil, including those involving ClearCorrect, a subsidiary of Straumann Group. Under the terms of the settlement, Straumann will pay Align $35M. Align and Straumann also signed a non-binding letter of intent for a 5-year global development and distribution agreement whereby Straumann would distribute 5,000 iTero Element scanners which would be fully integrated into the Straumann/Dental Wings CARE workflow. This device would offer users access to the Straumann CARES digital workflow, Straumann's CoDiagnostix guided implant surgery and ClearCorrect, in addition to the Invisalign workflow. Additionally, the parties are considering exploring the possibility of offering existing iTero users access to Straumann's prosthetic and surgical planning workflows. If for any reason the companies choose not to enter into the development and distribution agreement within 90 days of the Settlement Agreement's effective date, Straumann will pay Align an additional $16 million in lieu of the development and distribution agreement. Other terms of the settlement agreement are confidential. "This agreement brings an end to a series of patent disputes and allows both Align and Straumann to avoid the expense, uncertainty and distraction of continued litigation," said Roger George, Align Technology senior vice president and general counsel. "We can now turn our attention to the potential of an exciting new channel for iTero scanners and a digital integration partner in Straumann, recognized as a world leader in digital dentistry."

17:03 EDT Qiagen launches liquid biopsy solutions and NGS panels at AACR - QIAGEN announced the launch of new solutions designed to advance cancer research as part of its highlights at the American Association for Cancer Research 2019 Annual Meeting from March 29 to April 3, 2019, in Atlanta, Georgia. More than 30 studies being presented at AACR 2019 cite molecular testing tools from QIAGEN's Sample to Insight portfolio. These products involve: New solution bundles for all QIAseq and QIAact DNA panels for next-generation sequencing, integrating its market-leading CLC Genomics Workbench and QIAGEN Clinical Insight-Interpret software with these assays for seamless secondary analysis and tertiary interpretation of complex genomic data. QIAGEN is also introducing its exoRNeasy Midi and Maxi Kits for isolation of exosomes and other extracellular vesicles from urine and other samples, as well as the miRNeasy 96 Advanced QIAcube HT Kit for automated purification of total RNA, including miRNA, from serum and plasma samples. These are two novel liquid biopsy workflows for cancer research designed to enable non-invasive extraction and purification of ribonucleic acid.

16:57 EDT Chicken Soup for the Soul up 7.4% at $10.20 after Sony Pictures JV announcement

16:55 EDT Chicken Soup for the Soul forms joint venture with Sony Pictures - Sony Pictures Television (SNE) and Chicken Soup for the Soul Entertainment (CSSE) announced the signing of a definitive agreement to establish a new streaming video joint venture to be branded "Crackle Plus". SPT and CSS Entertainment will each contribute certain assets to establish Crackle Plus and position the new company as a leading AVOD streaming platform. Each company plans to bring its respective audience and its video-on-demand and content expertise to the joint venture. SPT's contributions to the joint venture include Crackle's U.S. assets including the Crackle brand, its monthly active users and its ad rep business. SPT and the joint venture will also enter into a license agreement for rights to popular TV series and movies from the Sony Pictures Entertainment library. In addition, New Media Services, a wholly-owned subsidiary of Sony Electronics Inc., will provide the technology back-end services for the newly formed joint venture.

16:39 EDT Progress Software up 20% to $46.01 after Q1 results, FY19 guidance top estimates

16:36 EDT RH reports Q4 comparable brand revenue up 5%

16:32 EDT Les Vinney to retire as Campbell Soup's board chairman - Campbell Soup announced that Les C. Vinney has chosen to retire as chairman of the board and as a director. The Board of Directors has elected Keith R. McLoughlin to succeed Vinney as Chairman. The board also announced the appointment of J.P. Bilbrey, former Chief Executive Officer of The Hershey Company, to the board, as well as the retirement of Sara Mathew. McLoughlin, 62, has been a Campbell director since 2015 and recently served as Campbell's Interim President and CEO from May 2018 until January 2019, where he oversaw the Board-led strategy and portfolio review. He stepped down from the interim role in January 2019 when Mark Clouse began as President and CEO.

16:23 EDT Eagle Materials holder Sachem Head reports 8.9% stake, to seek talks - In a regulatory filing, Sachem Head disclose a 8.9% stake in Eagle Materials, stating in the filing that they believe that the stock is "undervalued and is an attractive investment." Sachem Head said they intend to engage in discussions with the company, management and board of directors, other stockholders of the company and other interested parties on "issues that may relate to the business, management, operations including cost structure, assets, capitalization, financial condition, strategic plans, governance, board composition and the future" of the company.

16:19 EDT SAIC raises dividend by 6c to 37c per share, authorizes increase to buyback plan - Subsequent to fiscal year-end, the company's board approved an increase in its quarterly dividend of 6c per share, or approximately 20%, to 37c per share of the company's common stock payable on April 26 to stockholders of record on April 12. In addition, SAIC announced that its board has authorized an increase to its existing stock repurchase authorization of the company's common stock under an existing stock repurchase program. The current authorization increases the repurchase program to 16.4M shares, an increase of approximately 4.6M shares in order to make available for repurchase again an aggregate of 6.5M shares.

16:19 EDT EPR Properties names Greg Zimmerman as Chief Investment Officer - EPR Properties announced the hiring of Gregory E. Zimmerman as Executive Vice President and Chief Investment Officer commencing on April 15, 2019. Greg's career spans more than 25 years, including most recently positions as Executive Vice President, Development, of Washington Prime Group and Senior Vice President, Big Box, Theatre and Peripheral Development with Simon Property Group.

16:17 EDT UDR raises quarterly dividend by 6.2% to 34.25c per share - The dividend is payable in cash, on April 30, 2019 to UDR common stock shareholders of record as of April 9, 2019.

16:14 EDT Wells Fargo announces CEO Tim Sloan to retire effective June 30 - Wells Fargo announced that CEO and President Timothy Sloan has informed the company's board of directors of his decision to retire from the company, effective June 30, and to step down as CEO, president, and board member effective immediately. The board has elected C. Allen Parker, who served as the company's General Counsel, as interim CEO and President and member of the board, effective immediately. An external search process will now begin for the company's new CEO and President. Wells Fargo Board Chair Betsy Duke said, "Tim Sloan has served this company with pride and dedication for more than 31 years, including in his role as CEO since October 2016. He has worked tirelessly over this period for all of our stakeholders in the best long-term interest of Wells Fargo. His decision, and today's announcement, reflect that commitment and his belief that a new CEO at this time will best position the company for success...The board has a continuous succession planning process through which we identify potential successors within the company. Although we have many talented executives within the company, the board has concluded that seeking someone from the outside is the most effective way to complete the transformation at Wells Fargo. Accordingly, we will immediately initiate an external search and have selected Allen to serve as interim CEO. During this search period, the board and I will work closely with Allen and the company's leadership team to continue to move forward on Wells Fargo's goals and commitments. Since joining in early 2017 as our General Counsel, Allen has brought thoughtful and independent points of view to business, strategy, and governance matters, and he has earned the respect and full confidence of our Board and executive team as he takes on this interim CEO role."

16:12 EDT Biocept CEO says company has raised more than $18M in equity capital in 2019 - CEO Michael Nall said, "We have raised more than $18 million in equity capital since the beginning of 2019, and we now believe that we have the financial resources to implement our business strategy throughout the year. In addition to the expected growth in our U.S. laboratory testing business, we plan to increase additional Biocept testing in non-U.S. territories with our liquid biopsy kit strategy and to launch our molecular oncology multi-gene testing panel in the second quarter of 2019 to address the needs of our clinical, research and pharmaceutical company customers and prospective customers. We made good progress last year, and believe that this year is going to be an exciting and productive year for Biocept."

16:12 EDT VeriSign reports Q4 domain name registrations 348.7M, up 1.8% q/q and 4.9% y/y - VeriSign announced that Q4 closed with approximately 348.7M domain name registrations across all top-level domains , an increase of approximately 6.3M domain name registrations, or 1.8%, compared to the third quarter of 2018. Domain name registrations have grown by approximately 16.3M, or 4.9%, year over year.

16:11 EDT EMA accepts MAA for Dynavax's for Heplisav-B for prevention of Hep B in adults - Dynavax Technologies announced that the European Medicines Agency, EMA, has accepted the Company's Marketing Authorization Application, MAA, for review of HEPLISAV-B for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. This acceptance follows Dynavax's submission of the MAA on March 11 and marks the beginning of the regulatory review process for HEPLISAV-B in the European Union (EU). The outcome of the MAA review by the EMA is expected next year."The acceptance of the HEPLISAV-B application for review by the EMA signifies an important milestone in our journey to help prevent hepatitis B in adults through vaccination," said Robert Janssen, M.D., chief medical officer of Dynavax. "Many at-risk adults remain unprotected against this highly infectious virus. HEPLISAV-B has been shown to provide higher rates of protection with fewer doses than currently available vaccines. We hope to make HEPLISAV-B available beyond the U.S. to help address the global hepatitis B public health

16:06 EDT AngioDynamics receives expanded FDA clearance for electron radiation therapy - AngioDynamics announced that the FDA granted an expanded 510(k) clearance for the OARtrac Radiation Dose Monitoring System. The additional indications clear the OARtrac System for use with patient-specific, pre-calibrated peak skin dose sensors used during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning. The OARtrac System allows clinicians to measure and validate radiation doses targeted to a specific area of a patient's body, allowing for more accurate and informed dosing. The OARtrac System was previously cleared for use in the real-time monitoring and measurement of photon radiation and high dose rate brachytherapy during cancer treatments on both the skin surface and with endorectal balloon applications. The expanded Indication for Use now provides radiation oncologists and medical physicists with a tool to monitor and measure radiation doses in patients who receive electron radiation therapy, one of the most common radiotherapy treatments.

16:02 EDT Permit Enterprise, Hestia Capital announce slate for election to GameStop board - Hestia Capital Partners and Permit Capital Enterprise Fund are long-term stockholders of GameStop, with a combined ownership of approximately 1.3% of outstanding stock. Hestia Capital and Permit Enterprise announced that Hestia Capital has delivered to the company a formal notice of nomination of four highly qualified candidates: Don Bell III, Christopher Carvalho, Lizabeth Dunn, and Kurtis Wolf, for election to the board of directors of GameStop at the company's upcoming 2019 annual meeting of shareholders. Hestia Capital currently contemplates running three of the four nominees.

16:01 EDT DTE Energy accelerates carbon reduction goal by a decade - DTE Energy announced a bold new goal to reduce carbon emissions 80% by 2040 - accelerating by a full decade the carbon reduction commitment it made to Michigan residents and businesses just two years ago. In the company's Integrated Resource Plan being submitted to the Michigan Public Service Commission on Friday, DTE outlines the steps it will take over the next five years, and beyond, to transform to a cleaner generation mix - adding more renewables, increasing energy efficiency for its customers above state requirements and retiring coal plants sooner than previously announced. DTE also announced it will reduce carbon emissions at least 50% by 2030, surpassing its previous carbon reduction commitment of 45 percent by that timeframe.

14:23 EDT Craft Brew announces Christine Perich as Chief Financial and Strategy Officer - Craft Brew Alliance announced the appointment of Christine Perich as Chief Financial and Strategy Officer, effective April 1. Perich "spent 16 years at New Belgium Brewing Company, serving in successive leadership roles, including CFO, COO, and President and CEO until November 2016...Since 2017, Perich has expanded her leadership focus beyond the beer industry, establishing Perich Advisors, a strategy, culture and leadership development consultancy, and serving as CEO of WTRMLN WTR, a fast-growing juice brand, where she oversaw the successful launch of four new products, as well as major distribution expansion," Craft Brew stated.

14:02 EDT Buffett says Wells Fargo CEO Tim Sloan has his support '100%' - Warren Buffett is speaking with CNBC's Becky Quick.

13:59 EDT Assertio Therapeutics announces favorable ruling in NUCYNTA patent litigation - Assertio Therapeutics (ASRT) announced that the United States Court of Appeals for the Federal Circuit has ruled in favor of Assertio with respect to the company's patent litigation against three filers of Abbreviated New Drug Applications for the NUCYNTA franchise. The Federal Circuit's ruling affirms the decision of the United States District Court, which found U.S. patent No. 7,994,364 to be valid and infringed by the defendants. The '364 Patent covers the entire NUCYNTA franchise until December 2025. With the Court's ruling, the company expects market exclusivity until December 2025 for NUCYNTA ER, NUCYNTA and NUCYNTA oral solution. The NUCYNTA franchise is commercialized by Collegium Pharmaceutical (COLL). The company receives royalties from Collegium based on net sales of the franchise. Based on Collegium's current 2019 NUCYNTA franchise revenue guidance, the Company currently expects such royalties to be approximately $120M in 2019. The Federal Circuit affirmed the District Court's ruling with regard to U.S. patent No. 8,536,130 which upheld the validity of the '130 Patent but found that two of the three ANDA filers do not infringe the patent. The '130 Patent covers NUCYNTA ER until March 2029. The defendants in the appeal of the District Court's ruling in the patent litigation included Alkem Laboratories Limited, Hikma Pharmaceuticals International Limited and Actavis Elizabeth LLC, along with certain of their affiliated companies.

13:58 EDT Buffett says Apple should do things that don't work - Warren Buffett is speaking with CNBC's Becky Quick.

13:53 EDT Buffett says buying new offerings during 'hot periods' not for average person - Warren Buffett is speaking with CNBC's Becky Quick.

13:49 EDT Buffett on GM plant closures: Change part of capitalistic system - Warren Buffett is speaking with CNBC's Becky Quick

13:46 EDT Buffett says Boeing has a lot of work to do, promptly - Warren Buffett is speaking with CNBC's Becky Quick

13:44 EDT Buffett says Delta Air Lines stake 'accidentally' went above 10% - Warren Buffett is speaking with CNBC's Becky Quick.

13:38 EDT European Commission says 'EU scores final victory in the WTO Boeing dispute' - The EC said: "The EU welcomes today's ruling by the World Trade Organisation, WTO, Appellate Body, vindicating the EU's long held position that the United States has taken no steps to comply with WTO rules on support to Boeing (BA). The ruling concludes definitively that the US has continued to subsidize the company illegally despite previous rulings condemning this behavior. This has caused significant harm to its European competitor Airbus (EADSY).Today's ruling by the WTO's Appellate Body confirms the European Union's position that the United States has failed to remove the massive and trade distorting subsidies it is granting to Boeing. The WTO sided with the EU in its argument that several US measures, notably the Washington State tax program and business incentives from South Carolina are in fact subsidies. The Appellate Body dismissed all of the US appeal points. Commissioner for Trade Cecilia Malmstrom said: "Today's ruling is a welcome one for the EU, its aircraft-producing industry and workers across EU Member States in this strategic sector. The Appellate Body has now settled this case definitively, confirming our view the US has continued to subsidize Boeing despite WTO rulings to the contrary. We will continue to defend a level-playing field for our industry. European companies must be able to compete on fair and equal terms and today's ruling is important in this respect." Reference Link

13:22 EDT Aqua Metals jumps 10% after completion of Phase One of its capital program - Aqua Metals which is commercializing its proprietary AquaRefining electrochemical lead recycling, announced that all stockholder proposals were passed at the company's Annual Meeting of Stockholders held on March 27. The company also reviewed its operational progress at the meeting, including the completion of Phase One of its capital program, which should enable the start of scaling of the AquaRefinery early in the second quarter. "We appreciate the strong support of our stockholders to back our Board members, revitalize our employee equity incentive program for the first time since 2014 as well as provide for our existing and future partnerships," said Steve Cotton, Aqua Metals President and CEO. During the meeting, the Company announced the completion of Phase One of its capital program which includes the installation and start-up of its new filter press and installation of its new centrifuge. Together they provide continuous production of the concentrate sent to the AquaRefining modules at improved costs. Further, the Company announced the first full production run of lead bullion from its newly commissioned third kettle which should allow for an estimated 25% increase in lead metal production as well as improving overall contribution margin.Cotton added, "With these and other process improvements completed, we believe we are now in a position to scale our AquaRefinery with fiscal responsibility and commence full scale production with our initial four modules, including returning to 24x7 staffed operations early in the second quarter." Shares of Aqua Metals are up 29c or 9.8% to $3.2 in afternoon trading.

13:03 EDT Deutsche Bank, Nasdaq sign market technology agreement - Deutsche Bank Securities (DB) and Nasdaq (NDAQ) announced that Deutsche Bank's new Single Dealer Platform will be developed with Deutsche Bank, and hosted and operated by Nasdaq's market technology. The expected go-live is targeted for Q3. Deutsche Bank will leverage Nasdaq's market technology infrastructure to operate its US-based Single Dealer Platform. As a fully hosted platform, Nasdaq will also manage the system's operations, including portions of risk controls, venue surveillance, trade reporting and clearing facilitation.

12:50 EDT Natera says Palmetto issued local coverage determination for kidney test - Natera announced that Palmetto MolDx has issued draft local coverage determination for use of the company's new Prospera donor-derived cell-free DNA test to detect active rejection in kidney transplant recipients. In its draft LCD, Medicare states, "Prospera is an effective, non-invasive method of assessing kidney allograft status with better performance than the current standard-of-care," according to the company. Paul Billings, Natera's Chief Medical Officer, said, "I am pleased with the draft coverage decision and look forward to working with Medicare to make this test accessible for those in greatest need."

12:00 EDT Wabco falls -10.1% - Wabco is down -10.1%, or -$14.74 to $131.27.

12:00 EDT American Renal Associates falls -38.5% - American Renal Associates is down -38.5%, or -$3.73 to $5.97.

12:00 EDT PVH Corp. rises 14.4% - PVH Corp. is up 14.4%, or $15.97 to $126.86.

11:57 EDT Spotify begins testing Premium Duo, a plan for two people living together - Spotify has begun testing a new subscription plan called "Premium Duo," offering users two Spotify Premium subscriptions for a discounted price. The company said in a posting to its blog: "Premium Duo is the subscription plan for two people living together. Two Premium accounts, for one discounted price! Plus, you get Duo Mix! A playlist available in each account that matches both tastes. You both can find it on the desktop and mobile apps in Home , under Made For You." Reference Link

11:00 EDT Hanesbrands selected by UNC-Chapel Hill as primary licensed apparel partner - The University of North Carolina at Chapel Hill has selected Hanesbrands (HBI) as the University's primary licensee for apparel products, the university said in a statement. "The new agreement, which was executed in collaboration with its exclusive trademark licensing agent, IMG College Licensing, covers UNC-branded men's, women's, youth, and infant/toddler apparel across all retail channels, and ensures the University has greater control over the supply chain along with stability in licensing income over the next 10 years," it said. In addition to the new agreement with Hanesbrands, UNC-Chapel Hill will continue its partnership with Nike (NKE) and the Jordan Brand as exclusive suppliers of uniforms for the University's athletic teams, coaches, and staff, as well as licensed fan apparel.

10:26 EDT NY AG expands opiod suit against Purdue to six manufacturers, four distributors - New York Attorney General Letitia James said she has "filed the nation's most extensive lawsuit against the manufacturers, Sackler Family, and distributors of opioids for their role in the opioid epidemic that has taken hundreds of thousands of lives and devastated families and communities." The amended complaint expands an earlier lawsuit filed by the Office of the Attorney General against Purdue Pharma, and sets forth the Attorney General's findings from a multi-year, industry-wide investigation of these opioid market participants. The manufacturers named in the amended complaint include Purdue Pharma and its affiliates; members of the Sackler Family, the owners of Purdue, and trusts they control; Janssen Pharmaceuticals and its affiliates, including its parent company Johnson & Johnson (JNJ); Mallinckrodt (MNK) and its affiliates; Endo Health Solutions (ENDP) and its affiliates; Teva Pharmaceuticals USA (TEVA) and its affiliates; and Allergan Finance (AGN) and its affiliates. The distributors named in the complaint are McKesson (MKC), Cardinal Health (CAH), Amerisource Bergen (ABC) and Rochester Drug Cooperative. Reference Link

10:05 EDT Osmotica sinks 40% after multiple sclerosis drug fails to beat placebo - Osmotica Pharmaceuticals is trading lower after the company announced last night that arbaclofen did not demonstrate superiority to placebo in a study. The shares in early trading are down 40%, or $2.71, to $4.03. OS440-3004 was a double-blind placebo-controlled study in which multiple sclerosis patients with documented muscular spasticity in any limb received placebo, 40 mg arbaclofen per day, or 80 mg arbaclofen per day. The co-primary efficacy measures assessed in this study were Clinical Global Impression of Change and the change from baseline in the Total Numeric modified Ashworth Scale. Arbaclofen did not demonstrate superiority to placebo as measured by the CGIC; however, a statistically significant improvement in spasticity relative to placebo was demonstrated as measured by the TNmAS for 40 mg and 80 mg per day, respectively, Osmotica said. It added, "Upon preliminary review, it appears that CGIC failed to recognize the improvement demonstrated by the TNmAS. However, the CGIC values indicated both treatment groups improved from baseline. Further, the preliminary results appear to identify a dose-response relationship between the two strengths with the 80 mg dose exhibiting a stronger signal of efficacy as assessed by the spasticity scale. Though arbaclofen 80 mg per day had a higher discontinuation rate in the study, the safety and tolerability profile was in line with previously reported results, most notably a somnolence incidence of 9.5% and 14.5% for the 40-mg and 80-mg treatment arms, respectively, compared to 9.6% for the placebo treatment arm. Somnolence is one of the most frequently reported dose-limiting adverse events associated with baclofen treatment today. Further evaluation and additional analyses are ongoing, and we anticipate providing a further update once complete." The company went on, "We continue to believe that arbaclofen is a promising option for the treatment of spasticity in MS patients. While the topline results are disappointing, spasticity in MS remains an important unmet medical need, and, subject to completion of the data analysis and regulatory considerations we intend to continue to pursue submission of an arbaclofen NDA for review to the FDA although our timeline could now extend past 2019."

10:00 EDT Wabco falls -10.1% - Wabco is down -10.1%, or -$14.76 to $131.25.

10:00 EDT American Renal Associates falls -36.9% - American Renal Associates is down -36.9%, or -$3.58 to $6.12.

10:00 EDT PVH Corp. rises 17.3% - PVH Corp. is up 17.3%, or $19.18 to $130.06.

09:51 EDT 22nd Century to 'substantially increase' investment in hemp and cannabis - 22nd Century Group issued its annual letter to shareholders, in which the company stated in part: "All of that said, and as important as our tobacco initiatives are for the Company and for our shareholders, our strategic initiatives in hemp and cannabis - together with significant recent legislative changes - have combined to give our biotechnology efforts a massive boost in the emerging hemp/cannabis industry. By the end of 2018, more than half of U.S. states had approved the sale and use of medical cannabis, with another 10 states allowing adult, recreational consumption. Even more importantly, in an effort led by U.S. Senate Majority Leader Mitch McConnell, the U.S. federal government enacted the 2018 Farm Bill in December, including an important provision to legalize 'hemp,' which is defined as the cannabis plant containing not more than 0.3% THC. The enactment of this new federal law has accelerated hemp/cannabis biotechnology developments and spurred a slew of multi-million-dollar investments in hemp/cannabis production and extraction. 22nd Century is well positioned to take advantage of the opportunities represented by these changes in the federal law...Going forward, and as our PMT and MRTP applications progress through the FDA review process, 22nd Century will substantially increase its investment in the development of hemp/cannabis intellectual property. While our Company's molecular biotechnology laboratory is an important component in achieving our mission of creating new varieties of hemp/cannabis, our strategy also includes expanding our network of accomplished hemp and cannabis researchers, partner companies, and universities. To this end, 22nd Century is forming a vertically-integrated hemp and cannabis nexus that combines research, production, and extraction."

09:40 EDT Osmotica Pharmaceuticals PLC trading resumes

09:32 EDT Guardant Health announces Palmetto GBA LCD expanding Guardant360 assay coverage - Guardant Health announced that Palmetto GBA, a Medicare administrative contractor, has posted a draft local coverage determination, or LCD, expanding Medicare coverage of the Guardant360 assay from advanced non-small cell lung cancer, or NSCLC, to over a dozen advanced solid tumor cancer types with guideline-recommended genomic targets. The draft LCD would apply to advanced cancer patients who are covered by Medicare for next-generation sequencing of tumor tissue, but have insufficient or unavailable tissue samples. These cases may comprise a significant percentage of advanced cancers, especially those that have spread to the deep viscera, bone or brain.

09:25 EDT MYnd Analytics receives allowance for neuromodulation platform patent in Europe - MYnd Analytics announced it has received its first notice of patent allowance in Europe on the company's neuromodulation platform for predicting patients likely to respond to transcranial magnetic stimulation, or TMS. The allowed patent application has an anticipated expiration date in 2029. The patent has as its subject matter the company's proprietary process and proprietary outcome data on the use of individualized quantitative EEG features to predict non-response of individuals to TMS therapy. Although depression is the dominant indication for TMS, the FDA recently cleared a migraine/pain indication, and a deep-TMS protocol for obsessive compulsive disorder. TMS-derived interventions are also being developed and tested for Alzheimer's and anxiety. TMS is a non-invasive outpatient procedure that uses magnetic fields to stimulate areas of the brain thought to control mood. It is used as an alternative treatment for patients who have failed one or more antidepressants for the treatment of depression.

09:11 EDT Shineco to cooperate with Zhenye Agricultural for hemp plant in China - Shineco plans to cooperate with Heilongjiang Zhenye Agricultural, a professional industrial hemp planting enterprise, to establish China's largest planting and processing base for industrial hemp. The company, through its wholly owned subsidiary, Tenjove NewHemp Biotech, has entered into a strategic cooperation agreement for a share purchase agreement with Zhenye Agriculture. Through this cooperation, with the advantages of hemp floral leaf processing and integrated CBD product development, the TNB will provide Zhenye Agriculture with strains for medicinal use jointly developed by the Chinese Academy of Agricultural Sciences and the guidance of industrial hemp cultivation techniques. Zhenye Agriculture will become its professional production base. All the hemp products that Zhenye has planted belong to TNB, and Zhenye is expected to deliver the processed industrial cannabis leaves and other parts to the designated warehouse. TNB is expected to acquire 100% shareholder equity, all tangible assets, and relevant information in Zhenye Agriculture with a combination of shareholder equity and cash as consideration.

09:09 EDT Fly Intel: Pre-market Movers - HIGHER: Quantenna Communications (QTNA), up 18% after entering a definitive agreement for ON Semiconductor (ON) to acquire the company for $24.50 per share in an all cash transaction... SeaWorld (SEAS), up 3% after B. Riley FBR upgraded the stock to Buy from Neutral. UP AFTER EARNINGS: Lululemon (LULU), up 14%... Accenture (ACN), up 3%... Movado (MOV), up 13%. DOWN AFTER EARNINGS: LiqTech (LIQT), down 6%. LOWER: Wabco (WBC), down 10% after announcing ZF Friedrichshafen will acquire all outstanding shares of Wabco for $136.50 per share in an all-cash transaction for an equity value of over $7B... Fiat Chrysler (FCAU), down 2% after Reuters reports Volkswagen (VLKAY) CEO Herbert Diess said the automaker is not interested in a tie-up with Fiat Chrysler as the company is focusing its efforts internally... Proteon Therapeutics (PRTO), down 83% after reporting its PATENCY-2 trial did not meet its co-primary endpoints of fistula use for hemodialysis and secondary patency... FedEx (FDX), down 1% after being downgraded to Neutral from Positive at Susquehanna.

09:07 EDT DocuSign invests $15M in Seal Software for adoption of AI in contract analysis - DocuSign announced a $15M investment in artificial intelligence software provider Seal Software. The investment expands the partnership formed between DocuSign and Seal Software early last year, which saw Seal's artificial intelligence-based agreement discovery, extraction, and analytics solutions offered as a pre-integrated extension to DocuSign eSignature.

09:03 EDT Energy Recovery awarded $8.8M contract for water projects in Saudi Arabia - Energy Recovery announced total awards of $8.8M to supply its PX Q300 Pressure Exchanger devices to multiple desalination facilities in the Kingdom of Saudi Arabia. The devices are expected to ship in Q2. Energy Recovery estimates the PX Pressure Exchangers supplied to these desalination facilities will reduce power consumption for all projects by 54.3 MW.

08:58 EDT Maxim Integrated enters collaboration with Eccrine Systems - Eccrine Systems announced that it is collaborating with Maxim Integrated Products on the development and integration of analog signal processing technologies to drive Eccrine's sweat sensing platform. Maxim Ventures has invested in Eccrine as part of this collaboration. Eccrine is pioneering the field of pharmacoeccrinology, a non-invasive approach to precision medicine based on continuous measurements of drug and biomarker levels excreted in locally stimulated sweat. Personal drug response data is derived from sweat using Eccrine's electrochemical aptamer-based, or EAB, sensor platform. As sweat flows through the system, targeted drug and biomarker molecules interact with specially selected and modified DNA sequences on the sensor surface and cause a change in current indicating concentrations of the molecules. Continuous measurement of these molecules identifies patient responses to drug therapy with the promise of helping prescribers optimize individual dosing requirements more rapidly and cost-effectively.

08:50 EDT Cryoport's temperature-controlled solutions selected by Biokin Pharma - Cryoport's full suite of temperature-controlled solutions will support Biokin Pharma's pending Phase I and II clinical trials in immuno-oncology in both the U.S. and China. Biokin Pharmaceutical is a pharmaceutical company based in China focused on the treatment of cancer through developing novel therapeutic antibodies and antibody-drug conjugates. Its wholly-owned subsidiary SystImmune, which is funded in part by OrbiMed, was formed to advance its mission in the U.S. Partnering with Cryoport will enable Biokin Pharma and SystImmune to utilize Cryoport's temperature-controlled logistics solutions to support its drug manufacturing processes across the globe.

08:43 EDT Oramed granted U.S. patent for protease inhibitors - Oramed's U.S. patent for the technology "Protease Inhibitor-Containing Compositions, Compositions Comprising Same, and Methods for Producing and using Same" has been allowed by the USPTO. The protease inhibitors allow the insulin and other proteins to travel through the body intact.

08:33 EDT Amazon to expand Austin Tech Hub, create 800 new tech jobs - Amazon announced an expansion of its Austin Tech Hub and plans to create 800 new tech jobs in fields including software and hardware engineering, research science, and cloud computing. Together with its customer fulfillment facilities, Amazon has created more than 22,000 full-time jobs in Texas and since 2011 has invested over $7B in the state, including infrastructure and compensation to its employees.

08:27 EDT Movado up 13% to $37.00 after Q4 results top estimates

08:17 EDT Cinemark extends agreement for all Imax theaters - IMAX (IMAX) and Cinemark (CNK) are expanding the companies' partnership with the renewal of all Cinemark's existing IMAX locations and the installation of two IMAX with Laser systems. Cinemark will add IMAX's new laser experience and 12-channel sound system to a new IMAX theatre to be located at the Cinemark complex in Daly City, California as well as upgrade the existing IMAX theatre at the Cinemark complex in Milford, Connecticut. With this announcement, nearly all of Cinemark's IMAX theatres are now under agreement through 2026.

08:14 EDT Proteon Therapeutics PATENCY-2 trial did not meet co-primary endpoints - Proteon Therapeutics announced results from PATENCY-2, its Phase 3 clinical trial of investigational vonapanitase in patients with chronic kidney disease, or CKD, undergoing creation of a radiocephalic fistula for hemodialysis. This study did not meet its co-primary endpoints of fistula use for hemodialysis and secondary patency. The adverse events with vonapanitase were similar to placebo and consistent with previous clinical trials. PATENCY-2 evaluated the safety and efficacy of a single dose of investigational vonapanitase in patients with CKD undergoing creation of a radiocephalic arteriovenous fistula for hemodialysis. The multicenter, randomized, double-blind, placebo-controlled PATENCY-2 trial treated 603 patients at 39 medical centers in the United States and Canada. Patients were followed for up to one year. 69.7 % of vonapanitase-treated patients achieved use of the fistula for hemodialysis, compared to 65.1% of placebo-treated patients, a result that is not statistically significant. Fistula use is defined as use of the fistula for two-needle hemodialysis for at least 90 days or, if hemodialysis was not initiated at least 90 days prior to the last study visit, for at least 30 days and including the patient's last study visit. A comparison of the Kaplan-Meier curves did not demonstrate a statistically significant difference in favor of vonapanitase. At the end of one year, 78% of vonapanitase-treated patients maintained secondary patency, compared to 76% of placebo-treated patients. Secondary patency is a measure of the length of time from surgical creation of the fistula until the fistula experiences final failure and must be abandoned. Top-line results also included data relating to primary unassisted patency, one of PATENCY-2's other efficacy endpoints. Primary unassisted patency is the length of time from fistula surgical creation to the first occurrence of a fistula thrombosis or corrective procedure to restore or maintain patency. Vonapanitase-treated patients had a 15% reduction in the risk of primary unassisted patency loss over one year, compared to placebo, a result that is not statistically significant. At the end of one year, 50% of patients who received vonapanitase retained primary unassisted patency, compared to 43% of placebo-treated patients.

08:09 EDT ABM awarded custodial services contract by SASD in Wisconsin - ABM has been awarded a contract to provide a custodial services staffing solution to Sheboygan Area School District, or SASD, in eastern Wisconsin. The ABM education team will provide management oversight of an existing daytime custodial staff and add additional ABM employees for a nighttime shift at SASD's secondary schools. This includes four middle schools and four high schools that total approximately 1.5M square feet and serve 5,000 students.

08:08 EDT Citi Trends says Macellum is 'not aligned' with other shareholders - Citi Trends issued an open letter to its shareholders regarding Macellum SPV III, notice of its nomination of four individuals to stand for election to the Citi Trends Board of Directors at the Company's 2019 Annual Meeting of Shareholders. The letter read, in part, "Following Macellum's recent nomination of Board candidates, we are taking this opportunity to present the facts regarding Citi Trends' plan to drive value, describe the Board's attempts to reach a constructive resolution and avoid a prolonged proxy contest with Macellum, and correct the misinformation Macellum has put into the market. Citi Trends is executing on a strategic plan focused on growing our business by being the leader in providing value-priced urban fashions to our customers...Importantly, we are delivering results. In 2018, the Company reported comparable store sales increases in every quarter and delivered a full year comparable store sales increase of 1.6%. This increase was on top of a 4.5% increase the previous year. Additionally, the Company tightly managed its expenses, leading to an increase in adjusted earnings per diluted share of 59% in 2018 following a 13.2% increase in 2017...We remain focused on achieving our goal of reaching $4.00 of earnings per share within the next five years through a combination of merchandising, planning and allocation enhancements, cost-reduction initiatives and the return of excess capital to our shareholders...At Citi Trends, we are focused on our mission of delivering value-priced urban fashion apparel and accessories for the entire family. We provide our customers with a specialty store feel, while maintaining merchandise offerings that appeal to the fashion preferences of value-conscious consumers at prices that are 20% to 70% below regular retail prices available in department stores and specialty stores...Despite the Company's positive momentum, Macellum has provided its notice of intent to nominate at least three individuals to stand for election at the Company's 2019 Annual Meeting. This effort is being led by Macellum's founder, Jonathan Duskin, who ran a proxy fight two years ago leading to him joining the Company's Board. We believe Macellum's actions are a clear attempt to take control of Citi Trends' Board, despite only holding approximately 3.8% of the outstanding shares of the Company. Consistent with his tactics in his previous proxy fight against Citi Trends in 2017, Mr. Duskin has nominated more individuals than are currently up for election. We believe he has taken this path in an attempt to ensure he has maximum potential to gain control of the Board. It is worth noting that Macellum has sold approximately 38,000 shares since May 2018, while no other Citi Trends director has sold any shares during that same period. We believe Macellum selling your Company's shares underscores the fact that Mr. Duskin's interests are not aligned with those of other shareholders and our efforts to drive long-term sustainable growth at Citi Trends...In order to preclude Mr. Duskin from waging yet another costly and distracting proxy contest, the Citi Trends Board has held numerous discussions over the last few weeks with Mr. Duskin regarding board composition and the Board's commitment to regular refreshment. The Board has attempted to reach a resolution that benefits all shareholders, but Mr. Duskin has refused our offers...The Citi Trends Board, excluding Mr. Duskin, comprises six highly qualified directors, five of whom are independent, and all of whom are actively engaged in the execution of the Company's plan. Four new directors, two of whom are women, were added to the Board in the past four years and the Board has reduced the average tenure of its independent board members to approximately six and a half years...The Citi Trends Board believes letting a 3.8% shareholder, who we believe solely has short-term interests, control 57% of the Board would be destructive to the Company's future. We appreciate the interest and support of all Citi Trends shareholders. We remain open to constructive suggestions and look forward to continuing to engage with shareholders as we work to drive sustainable, long-term value. "

08:05 EDT China Recycling Energy reports agreement of intent with Quingzhou Taihuacheng - China Recycling Energy announced that Shanghai TCH Energy Technology Co., Ltd., a wholly-owned subsidiary of the company, entered into an Agreement of Intent with Qingzhou Taihuacheng Real Estate Development and Management to build an energy storage power station with total capacity of 50 MWH. China Recycling says, "According to the agreement of intent, we will build an energy storage power station for Taihuacheng to realize three functions of reliable electricity consumption, high quality electricity consumption and economical electricity consumption.Our energy storage power station uses the energy storage battery to charge power from the grid during peak-off hours and discharge to their electrical equipment during peak hours, so as to save the cost of electricity by taking advantage of the difference in electricity prices between the peak and peak-off hours. At the same time, ensure that the important load of Taihuacheng won't power outages as well as guarantee high quality power supply for its equipped precision equipment."

08:03 EDT Ovid Therapeutics says CMO Amit Rakhit to add role of head of R&D - Ovid Therapeutics announced changes to its senior management team to focus the company's resources and attention on its late stage pipeline. Amit Rakhit, M.D., MBA, is adding the role of Head of R&D to his current position as Chief Medical Officer. Matthew During, M.D., D.Sc., will transition out of his role as President and Chief Scientific Officer while becoming Chairman of the company's Scientific Advisory Board. As part of this transition, Dr. During has decided not to stand for reelection following his current term on Ovid's Board of Directors. Rakhit will be responsible for all aspects of Ovid's pipeline and development strategy.

08:02 EDT Wabco CEO: Deal is 'the right combination at the right price at the right time'

08:00 EDT Wabco to be acquired by ZF Friedrichshafen for $136.50 per share in cash

07:55 EDT Proteon Therapeutics trading halted, news pending

07:50 EDT Jacobs Engineering awarded land remediation services by Army Corps of Engineers - Jacobs has received Notice to Proceed for a single-award contract from the U.S. Army Corps of Engineers Buffalo District for remediation services required at the Formerly Utilized Sites Remedial Action Program Shallow Land Disposal Area site in Parks Township, Pennsylvania. Support includes development of work site and safety plans as well as excavation, storage and transport processing of radioactively contaminated soils and waste. USACE estimates the 10-year indefinite delivery/indefinite quantity single-award task order contract to include a five-year base period and a five-year option period with a capacity value of $350M.

07:48 EDT Oxford Immunotec to collaborate with Generium for T-SPOT.TB distribution - Oxford Immunotec announced a new local production initiative to bring the benefits of the T-SPOT.TB test to the Russian Federation. Since the T-SPOT.TB test received approval in the Russian Federation in 2013, Oxford Immunotec has been working with a local distribution partner, PharmLine and has seen expanding uptake of the T-SPOT.TB test. In collaboration with PharmLine, Oxford Immunotec will now also be working with Generium, who will be manufacturing the T-SPOT.TB test locally at their factory in the Vladimir region of the Russian Federation. This is expected to reduce the cost of, and expand access to, the T-SPOT.TB test for patients in the Russian Federation. Additionally, Generium will be working with PharmLine on marketing and distribution of the T-SPOT.TB test, including applying for national TB control tenders.

07:42 EDT HUD charges Facebook with violating Fair Housing Act through ad platform - The U.S. Department of Housing and Urban Development announced that it is charging Facebook with violating the Fair Housing Act by "encouraging, enabling, and causing housing discrimination" through the company's advertising platform. The action follows HUD's investigation of a Secretary-initiated complaint filed on August 13, 2018. HUD alleges that Facebook "unlawfully discriminates based on race, color, national origin, religion, familial status, sex, and disability by restricting who can view housing-related ads on Facebook's platforms and across the internet. Further, HUD claims Facebook mines extensive data about its users and then uses those data to determine which of its users view housing-related ads based, in part, on these protected characteristics." Facebook shares are down $1.81 to $165.87 in premarket trading. Reference Link

07:37 EDT OpGen announces publication of data on antibiotic resistance using Acuitas - OpGen (OPGN) announced that data supporting prediction of antibiotic resistance using the company's Acuitas AMR Gene Panel and Acuitas Lighthouse Software was published in the April issue of Antimicrobial Agents and Chemotherapy, a peer-reviewed scientific journal from the American Society for Microbiology. The manuscript highlights results from a rapid, high-throughput PCR test that evaluated more than 7,500 highly antibiotic-resistant clinical isolates of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and Pseudomonas aeruginosa selected from Merck's (MRK) study for monitoring antimicrobial resistance trends surveillance network to predict phenotypic resistance to several antibiotic classes. The study developed statistical methods to predict phenotypic resistance from resistance genes for various combinations of the four bacterial species and the antibiotics gentamicin, tobramycin, ciprofloxacin, levofloxacin, trimethoprim-sulfamethoxazole, ertapenem, imipenem, cefazolin, cefepime, cefotaxime, ceftazidime, ceftriaxone, ampicillin, piperacillin and aztreonam. Average positive predictive values for predicting phenotypic resistance were 91% for E. coli, 93% for K. pneumoniae, 87% for P. mirabilis, and 92% for P. aeruginosa.

07:25 EDT Rhythm Pharmaceuticals announces interim data from Phase 2 setmelanotid study - Rhythm Pharmaceuticals announced updated interim data from its ongoing Phase 2 basket study of setmelanotide in melanocortin-4 receptor, or MC4R, pathway heterozygous, or HET, obesity. In addition, the company unveiled plans to continue evaluating setmelanotide in HET obesity, with patients enrolled into cohorts based on their loss-of-function, or LOF, variants. This decision is based primarily on clinical results, which show a more consistent treatment benefit in patients with higher-impact LOF variants. Rhythm announced preliminary data from 13 HET patients who were treated with setmelanotide, including four patients with high-impact LOF variants and nine patients with other LOF variants. All four patients with high-impact LOF variants remain on therapy, including two patients who have been on treatment for more than 29 weeks. The first patient, who entered the study weighing 451 pounds, lost 40.5 pounds and experienced a hunger score decrease of 90% after 37 weeks of treatment with setmelanotide. The second patient, who entered the study weighing 284 pounds, lost 49 pounds and experienced a hunger score decrease of 71.4% after 29 weeks of treatment. The two additional patients have been on treatment for a short duration and are showing promising weight loss and hunger score decreases during dose titration. Five of nine patients with other LOF variants remain on therapy, with treatment durations ranging from seven to 74 weeks. This includes the two responding patients on whom Rhythm reported data in June 2018. Across these five patients, one experienced a clinically-meaningful weight loss of greater than 10%, three experienced weight loss between 5% and 8% and one has been on treatment for a short duration and it is too early to assess response to therapy. Among the four response-evaluable patients, hunger score decreases ranged from 20%-80%. Four of nine patients with other LOF variants discontinued treatment, including one patient who was discontinued due to lack of efficacy. The other three patients were discontinued following less than four weeks on therapy and therefore efficacy could not be evaluated. This includes the two patients on whom Rhythm reported in June 2018, both discontinued due to adverse events, or AEs. In addition, one patient was withdrawn by the site for patient non-compliance. Consistent with prior clinical experience, setmelanotide continues to be well-tolerated. There were no serious AEs reported and no new discontinuations due to AEs since those reported in June 2018. Rhythm plans to continue enrolling HET patients in its Phase 2 basket study in cohorts stratified by LOF variant. In addition to pursuing proof-of-concept in high-impact LOF variants, Rhythm also plans to explore setmelanotide's potential in additional patient cohorts, including patients with partial LOF or newly-characterized variants, patients with more common variants and patients with composite HET variants. Rhythm expects patient enrollment to continue at least through the remainder of the year, with updated data to follow in 2020. Rhythm anticipates that these data will help inform the most appropriate strategy to support the potential registration and approval of setmelanotide for the treatment of setmelanotide-responsive subgroups of HET obesity. In parallel, Rhythm intends to further ongoing efforts to better understand HET obesity and facilitate patient identification. In order to add to the pool of high-impact variants, Rhythm is undertaking a comprehensive effort to screen and classify new and uncharacterized variants in the MC4R pathway, using both computational models for assessing variants and biochemical analysis of variants in POMC, PCSK1, and LEPR to assess functional impact.

07:20 EDT Allegheny Technologies wins $45M supply contract for deepwater pipeline - Allegheny Technologies has been selected to supply the nickel-based flat rolled products for a large oil pipeline project in South America. Revenue to the ATI Flat Rolled Products, or FRP, segment is expected to be approximately $45M, with shipments beginning in second quarter 2019 and scheduled to be completed by year-end.

07:15 EDT GasLog subsidiary signs charter party agreement with LMT for HN 2274 - GasLog (GLOG) announced that a wholly owned subsidiary of the company has signed long-term time charter party agreement with LNG Marine Transport, or LMT, the principal LNG shipping entity of Japan's Jera, for its existing uncommitted newbuild vessel, HN 2274. GasLog is scheduled to take delivery of the vessel, a 180,000 cubic meter Mark III Flex Plus design with low pressure two stroke propulsion, from Samsung (SSNLF) Heavy Industries in April 2020, at which point it will commence the 12-year fixed-term time charter. HN 2274 is scheduled to be delivered to Jera in April 2020 for a fixed 12-year term. The rate of hire for the charter is in line with mid-cycle rates and is expected to deliver attractive returns for GasLog's shareholders. Following the commencement of the 12-year charter to Jera, GasLog Partners (GLOP) will have the right to acquire HN 2274 pursuant to the omnibus agreement between GasLog and GasLog Partners. As a result, GasLog Partners' potential dropdown pipeline will increase to 13 LNG carriers with charter length of five years or longer.

07:12 EDT Aptinyx to present detailed results from Phase 2 NYX-2925 at APSS meeting - Aptinyx announced an upcoming poster presentation highlighting the detailed results from a recently completed Phase 2 study of NYX-2925 for the treatment of painful diabetic peripheral neuropathy. The poster presentation will take place at the American Pain Society Scientific Meeting in Milwaukee, Wisconsin on April 4."While we announced in January that the study did not meet the primary endpoint in the total study population, the findings from the detailed analysis provide a strong scientific foundation for advancing the development of NYX-2925 for the treatment of chronic pain," said Norbert Riedel, president and chief executive officer of Aptinyx. "The mechanism of NYX-2925 is particularly relevant to the central pain perception and processing that occurs as chronic pain persists, and we are very encouraged to see that those patients in the study who had DPN for a longer period of time showed a robust and clinically significant treatment benefit from NYX-2925 across multiple endpoints. Not only is this a critical finding based on our mechanism, but it also suggests the potential of NYX-2925 to address a major unmet medical need. Importantly, the detailed results from the study also inform future development of NYX-2925 in painful DPN. We look forward to presenting the detailed analysis at the APS Scientific Meeting."

07:07 EDT Titan Pharmaceuticals partners with AppianRx for Probuphine patient services - Titan Pharmaceuticals has executed a service agreement with AppianRx, a specialty healthcare solutions company, to provide a full suite of patient support services such as product ordering and payor pre-approval related to Probuphine, or buprenorphine, implant, Titan's six-month maintenance treatment for opioid use disorder in eligible patients.

07:04 EDT Pareteum wins $50M global expansion contract with Streaming Media Brand - Pareteum's solution has been selected to power the international expansion of a digital services brands in the Middle East and Africa region. Pareteum's newest customer is launching a business model, enabled by Pareteum, that serves Middle East and African origin digital content and services, to citizens of those regions who are now residing in the UK and US. This customer will launch its cross-border services, using Pareteum's Global Software Cloud Platform, which are expected to begin in June 2019. The initial phase of the contract is valued in excess of $50M, which is incremental to Pareteum's 36-month contractual revenue backlog.

07:04 EDT Plug Power announces commercial launch of 30kW hydrogen ProGen engine - Plug Power announced the launch of its 30 kilowatt hydrogen fuel cell engine, the newest commercial product from the ProGen suite of products. Delivery of the first commercial orders for this product are scheduled in July 2019 to European and Asian on-road e-mobility applications.

07:02 EDT Madrigal Pharmaceuticals initiates Phase 3 study of NASH candidate resmetirom - Madrigal Pharmaceuticals has initiated its Phase 3 trial in NASH with its once daily, oral thyroid hormone receptor beta selective agonist, MGL-3196, resmetirom. Patients with liver biopsy confirmed NASH with stage 2 or 3 fibrosis will be randomized 1:1:1 to receive a single oral daily dose of placebo, resmetirom 80 mg or resmetirom 100 mg. The primary endpoint will be the percent of patients treated with either dose of resmetirom as compared with placebo who achieve NASH resolution on the week 52 liver biopsy, and no worsening of fibrosis stage. Two key secondary endpoints are reduction in LDL-cholesterol and a 1-point or more improvement in fibrosis stage on the week 52 biopsy with no worsening of NASH. Patients will continue in the study for a total of 54 months. Madrigal CEO Paul Friedman stated, "In the 36 Week Phase 2 study, NASH resolution was highly correlated with the magnitude of liver fat reduction on MRI-PDFF. In Phase 2, 25% of all resmetirom treated patients, and 37% of treated patients who were on adequate doses of resmetirom, achieved the Phase 3 NASH resolution endpoint; both results demonstrated statistically significant differences relative to placebo."

06:57 EDT Church & Dwight to acquire Flawless brand for $475M plus earn-out - Church & Dwight has signed a definitive agreement with Ideavillage Products to acquire the Flawless and Finishing Touch brands of hair removal products, for approximately $475M in cash plus an additional earn-out payment of up to a maximum of $425M, in cash, based on a twelve-month net sales target ending no later than December 31, 2021. The transaction is expected to close in Q2. Flawless' net sales for the trailing twelve months ended December 31, 2018 were approximately $180M with EBITDA approximating $55M or approximately 30% EBITDA margin, over the same period. The products are marketed in the U.S. and over 30 countries. Approximately 10% of net sales come from international markets.

06:54 EDT Accenture raises FY19 free cash flow view to $5.2B-$5.6B from $5.1B-$5.5B

06:48 EDT Goldman Sachs fined EUR34M by FCA for misreporting transactions - Goldman Sachs International has been fined EUR34.34M by the Financial Conduct Authority for failing to provide accurate and timely reporting relating to 220.2 million transaction reports between November 2007 and March 2017. Mark Steward, FCA Executive Director of Enforcement and Market Oversight said: "GSI failed to ensure it provided complete, accurate and timely information in relation to approximately 213.6m reportable transactions. It also erroneously reported 6.6m transactions to the FCA, which were not, in fact, reportable. Altogether, over a period of 9 and a half years, GSI made 220.2m errors in its transaction reporting, breaching FCA rules. The FCA also found that GSI failed to take reasonable care to organise and control its affairs responsibly and effectively in respect of its transaction reporting. These failings related to aspects of GSI's change management processes, its maintenance of the counterparty reference data used in its reporting and how it tested whether all the transactions it reported to the FCA were accurate and complete. GSI agreed to resolve the case and so qualified for a 30% discount in the overall penalty. Without this discount, the FCA would have imposed a financial penalty of GBP49.06M."

06:33 EDT Stage Stores reaffirms previously announced guidance - Inclusive of the acceleration and expansion of the off-price conversion strategy, the company is reaffirming its previously announced guidance for sales, earnings, and capital.

06:32 EDT Stage Stores accelerates, expands rollout of off-price growth strategy - Stage Stores announced that, following strong results for both the 9 off-price conversions completed in 2018 and the 37 off-price conversions completed in the first quarter of 2019, the company is accelerating and expanding the rollout of its off-price growth strategy. The 35 second quarter conversions, which were previously planned for back-to-school, will now be completed in June, and an additional 10 to 15 stores will be converting in the third quarter. With approximately 85 total conversions in 2019, the company now expects to end the year with approximately 150 off-price stores along with an additional 150 off-price conversions planned for the first half of fiscal 2020. "We are extremely pleased with the initial sales results in our March off-price conversions. They have clearly exceeded our expectations and have continued the momentum that began with our 2018 converted stores," said Michael Glazer, President and CEO. "Notably, through mid-March, sales in our 2018 small market conversions have increased more than 150% since they were converted compared to their department store results. Based on the strong results we have seen across our converted store base, we are thrilled to further accelerate and expand our off-price growth strategy. We now expect to enter the second half of 2020 with more than 300 Gordmans off-price stores, which will represent approximately half our total sales volume. With higher sales, improving store profitability, and faster inventory turns, our off-price strategy bodes well for our earnings and cash flow performance."

06:12 EDT Daimler, Geely form JV to develop smart brand as all electric carmaker - Daimler and Zhejiang Geely Holding announced the formation of a 50-50 "globally focused joint venture to own, operate and further develop smart, the pioneer of small urban vehicles, as a leader in premium-electrified vehicles." Under the joint venture agreement, a new generation of smart electric models will be assembled at a new purpose-built electric car factory in China with global sales due to begin in 2022. The board of directors of the new smart joint venture will be made up of six executives with equal representation from both parties. The joint venture partners have agreed that the new generation of smart vehicles will be styled by the worldwide Mercedes-Benz Design network with engineering from Geely global engineering centers. Future production will be located in China. As part of the vehicle-development program, the smart product portfolio is also planned to be extended into the B-segment. Prior to the launch of new models from 2022 onwards, Daimler will continue to produce the current generation of smart vehicles in its Hambach plant France and at Novo Mesto.

05:45 EDT Manchester United announces Ole Gunnar Solskjaer as full-time manager - Manchester United announces that current caretaker manager and former striker, Ole Gunnar Solskjaer, has been appointed as the club's full-time manager on a three-year contract. Solskjaer scored 126 goals in 366 appearances for United between 1996 and 2007 and also managed the club's reserve team until the end of 2010. He was appointed Caretaker Manager on 19th December 2018 and won his first eight games in charge on the way to an overall record of 14 victories and two draws in 19 games, amassing more Premier League points than any other club during that time.

05:39 EDT Seattle Genetics, Astellas Pharma announce topline results of EV-201 trial - Seattle Genetics (SGEN) and Astellas Pharma (ALPMY) announced positive topline results from the first cohort of patients in a pivotal phase 2 single-arm clinical trial known as EV-201. The cohort is evaluating enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have received previous treatment with both platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor. Results showed a 44 percent objective response rate, or ORR, per blinded independent central review. The duration of response was consistent with that recently reported in the previous phase 1 study, or EV-101. The most common treatment-related adverse events included fatigue, alopecia, decreased appetite, rash and peripheral neuropathy. The data will be presented at an upcoming medical meeting. Enfortumab vedotin is an investigational antibody-drug conjugate, or ADC, that targets Nectin-4, a therapeutic target that is highly expressed in multiple solid tumors including urothelial cancers. Based on preliminary results from a phase 1 trial, or EV-101, enfortumab vedotin was granted Breakthrough Therapy designation by the FDA for patients with locally advanced or metastatic urothelial cancer whose disease has progressed during or following treatment with a PD-1 or PD-L1 inhibitor. The companies plan to submit a Biologics License Application, or BLA, to the FDA later this year based on the results from the EV-201 trial. A global, randomized phase 3 clinical trial is ongoing and intended to support global registration as well as to serve as the confirmatory randomized trial for enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.