Stockwinners Market Radar for January 07, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:23 EDT Grana y Montero's Concar unit awarded road management contract - Grana y Montero S.A.A. announced that Concar, a subsidiary of Grupo Grana y Montero, has been awarded the "Road management and conservation by levels of service of the road corridor: Atico - DV. Quilca - Matarani - Ilo y Punta de Bombon - DV. Cocachacra - Emp. Pe - 1S", located between Arequipa and Ilo. The contract covered the road management and conservation works of the aforementioned road corridor. The supervision is in charge of the Special Project of National Transportation Infrastructure (Provias Nacional), entity part of the Ministry of Transport and Communications and is responsible for providing road infrastructure throughout the country. The project will demand an approximate activity of S/. 32.4 million soles in addition to the general tax sales according to the terms of the agreement, and has a duration of 3 years.

19:06 EDT Samsung down over 2% in early Kospi trade after preliminary Q4 results

19:00 EDT Gridsum receives Nasdaq noncompliance notice - Gridsum Holding reported that it has received a letter from the Listing Qualifications Department of The Nasdaq Stock Market, dated January 2, 2019, notifying the company that it was not in compliance with the requirements for continued listing under Nasdaq Listing Rule 5250c2 because it did not file its report on Form 6-K containing an interim balance sheet and income statement for the six month period ended June 30, 2018, by December 31, 2018. As described in the letter, the failure to file the 2018 Interim Report qualified as a separate basis for delisting which the Nasdaq Hearings Panel would consider in connection with the company's listing, and allowing the company to present its views with respect to the additional deficiency in a letter to the Panel no later than January 9, 2019. Separately, on January 4, 2019, the company received a letter from the Panel indicating that the Panel had granted the company until the company's requested date of January 31, 2019 to regain compliance with its reporting obligations, and requesting that the company provide the Panel with an update with respect to, among other things, the completion of the company's audit and filing of the company's Annual Report on Form 20-F for the year ended December 31, 2017, by no later than January 11, 2019. The company provided a response to both letters on January 7, 2019. Later on January 7, 2019, the company filed both the 2017 Annual Report and the 2018 Interim Report with the SEC; therefore, the company has now filed all periodic reports required under applicable SEC and Nasdaq regulations.

18:50 EDT OMA Airports reports 9.4% increase in December passenger traffic - OMA Airports reports that terminal passenger traffic at its 13 airports increased 9.4% in December 2018, as compared to December 2017. Domestic traffic increased 10.1%, and international traffic increased 4.8%.

18:33 EDT KDDI and AT&T to connect Toyota and Lexus vehicles - Toyota and Lexus are bringing industry-leading connected car capabilities to their vehicles in the United States. The collaboration of Toyota Motor (TM) North America, KDDI (KDDIY) and AT&T (T) will enable 4G LTE connectivity for select new model Toyota and Lexus cars and trucks. This will start with 2020 model year vehicles in the fall of 2019, across all 50 states. The ecosystem will build on the joint Global Communications Platform announced by Toyota and KDDI in 2016 to support car connectivity. Features will include: Wi-Fi hotspots so owners of select Toyota and Lexus vehicles can stream, browse and share entertainment among multiple smartphones and tablets from the open road; Unlimited data plans offered by AT&T for eligible Toyota and Lexus vehicles; Remote start to crank up your car remotely and start up the heat or A/C; Remote diagnostics to provide vehicle health information to customers and dealers; Destination Assist to provide peace of mind and convenience by downloading vehicle destinations to navigation systems; Safety Connect to help in an emergency by connecting drivers to a 24/7 response center at the touch of a button.

18:01 EDT Consolidated Water provides update on Rosarito project - Consolidated Water provided an update on the status of its on-going project to construct and operate a desalination plant and accompanying pipeline in Rosarito, Baja California, Mexico. On December 31, 2018, the Congressional authorization for the execution of the credit agreement to guarantee the payment obligations of the public entities under the project's contract expired. Mexican State officials have informed Consolidated Water that they will seek another amendment of Decreto #57, as amended by Decreto #168, to extend the authorization for the execution of such credit agreement, which will enable the project to proceed. The company and its partners in the project, Greenfield SPV VII, an affiliate of a leading U.S. asset management firm, and SUEZ, a global leader in water treatment have extended the deadline for the satisfaction of the conditions of the February 2018 share subscription agreement to June 30, 2019. CEO Rick McTaggart commented, "Although the State was unable to finalize its credit facility prior to the expiration date of Decreto #57, we appreciate the complexity and amount of time involved in negotiating a credit facility of this importance, and we are encouraged by the feedback we have received from State authorities, who have communicated to us that they continue to fully support the project and are seeking to obtain another amendment to Decreto #57, and to finalize the credit facility in the coming months. We and our partners believe the project is the only viable solution presently available to address the growing water needs of the Baja region and are confident that the State authorities similarly recognize the great need for the project."

17:51 EDT First Financial, HopFed Bancorp to merge - First Financial Corporation (THFF) and HopFed Bancorp (HFBC) jointly announced the execution of a definitive merger agreement under which HFBC will merge into First Financial in a cash and stock transaction. Upon completion of the merger, Heritage Bank USA, a wholly owned subsidiary of HFBC, will merge into First Financial Bank, a wholly owned subsidiary of First Financial. Under the terms of the merger agreement, which was unanimously approved by the boards of both companies, stockholders of HFBC may elect to receive either 0.444 shares of First Financial common stock or $21.00 in cash for each share of HFBC common stock owned, subject to proration provisions specified in the merger agreement that provide for a targeted aggregate split of 50% of HFBC shares being exchanged for First Financial common stock and 50% for cash. Based upon First Financial's closing price of $43.01 on January 4, and assuming that a shareholder received 50% stock and 50% cash, the purchase price would be worth $20.05 per share, with an aggregate transaction value of approximately $128.3M.

17:43 EDT Akamai acquires customer identity access management firm Janrain - Akamai Technologies announces the company has entered into an agreement to acquire Janrain, "the company that pioneered the customer identity access management, CIAM, category." Janrain enables enterprises to enhance digital trust by offloading login and registration workloads, and its integration with Akamai's Intelligent Edge Platform is expected to provide world class security, regulatory compliance and massive scale to online engagements. Janrain is a privately-funded company headquartered in Portland, Oregon. The all-cash transaction is expected to close early in the first quarter of 2019. Akamai anticipates the Janrain acquisition to be slightly dilutive to its non-GAAP net income per share for 2019, in the range of 5c to 6c, and to become accretive in 2020. The acquisition is not expected to impact Akamai's previously-stated goal of achieving a non-GAAP operating margin of 30% by 2020.

17:29 EDT Union Pacific spikes about 7% after naming Jim Vena COO - Shares of Union Pacific are up 6.8% or $9.40 per share to $148 per share in after-hours trading.

17:25 EDT HopFed Bancorp trading halted, news pending

17:23 EDT Correct: Carl Icahn discloses 6.3% passive stake in Dell Technologies

17:17 EDT Akorn says Bruce Kutinsky no longer COO effective December 31 - On January 7, Akorn and Bruce Kutinsky entered into a letter agreement agreeing that Kutinsky will no longer serve as COO of the company effective December 31. The letter agreement provides for certain terms in connection with Kutinsky's departure from the company. Pursuant to the letter agreement, Kutinsky will serve in a consulting role to the company and will be reasonably available to the President and CEO and the management team to provide transition and consulting related support from January 1, 2019 through March 31, 2019, and further to provide support to the company's legal department through December 31, 2019 pursuant to a separate agreement, which Kutinsky and the Company have agreed to endeavor to enter into at a later date.

17:09 EDT Santander Chile, Latam Airlines extend strategic alliance - Banco Santander Chile (BSAC) has agreed with LATAM Airlines (LTM) to renew and extend for seven years the commercial and strategic alliance that they have maintained for 24 years and that will benefit more than 1M customers included in theSantander Latam Pass program.

17:02 EDT Nvidia introduces Drive AutoPilot Level 2+ driving system - NVIDIA announced the world's first commercially available Level 2+ automated driving system, Nvidia Drive AutoPilot, which integrates multiple breakthrough AI technologies that will enable supervised self-driving vehicles to go into production by next year. At CES 2019, leading automotive suppliers Continental and ZF announced Level 2+ self-driving solutions based on NVIDIA DRIVE, with production starting in 2020. As a Level 2+ self-driving solution, Nvidia Drive AutoPilot uniquely provides both world-class autonomous driving perception and a cockpit rich in AI capabilities. Vehicle manufacturers can use it to bring to market sophisticated automated driving features - as well as intelligent cockpit assistance and visualization capabilities - that far surpass today's ADAS offerings in performance, functionality and road safety. Drive AutoPilot integrates for the first time high-performance NVIDIA Xavier system-on-a-chip processors and the latest Nvida Drive Software to process many deep neural networks for perception as well as complete surround camera sensor data from outside the vehicle and inside the cabin. This combination enables full self-driving autopilot capabilities, including highway merge, lane change, lane splits and personal mapping. Inside the cabin, features include driver monitoring, AI copilot capabilities and advanced in-cabin visualization of the vehicle's computer vision system.

16:52 EDT Medidata appoints Sastry Chilukuri as EVP digital and AI solutions - Medidata announced the addition of executive vice president of Digital and AI Solutions, Sastry Chilukuri to its senior leadership team.

16:49 EDT Azul reports December consolidated passenger traffic up 13.4% - Azul announces its preliminary traffic results for December 2018. Consolidated passenger traffic, RPKs, increased 13.4% compared to December 2017 on a capacity increase, ASKs, of 13.5% resulting in a load factor of 83.0%, mostly in line with the 83.1% recorded in December 2017. Domestic load factor was 81.3%, representing a decrease of 0.4 p.p. compared to the same period in 2017 while international load factor was 88.0%, up 0.6 p.p.."December was another strong month for Azul as we continue to execute on our fleet transformation strategy backed by a solid demand environment. We received another two A320neos in December, ending the year with 20 aircraft of this type. As we move forward, we continue to be very excited about our fleet transformation process and the results we are seeing from it", says John Rodgerson, Azul's CEO.

16:37 EDT Brink's says McAlister Marshall to step down from role as General Counsel, CAO - On December 31, the Brink's Company and McAlister C. Marshall, II mutually agreed that Mr. Marshall would step down from his role as Senior Vice President, General Counsel and Chief Administrative Officer. In connection with this transition, the company and Mr. Marshall entered into an agreement pursuant to which Mr. Marshall will remain an employee of the company for a period commencing on January 1, 2019 and ending on December 31, 2019, during which period Mr. Marshall will assist with transitioning his executive responsibilities to his successor and with other legal matters and special projects.

16:34 EDT Ellomay Capital receives non-compliance notice from NYSE - Ellomay Capital announced that it received a letter from NYSE indicating that in connection with the end of the service term of one of the company's external directors on December 29, 2018 the company is currently not in compliance with the audit committee composition requirements set forth in section 803 of the NYSE company guide. NYSE advised in the letter that the company has until the earlier of its next annual meeting or December 29 to regain compliance with the audit committee composition requirements. The company previously published a notice and proxy statement in connection with an extraordinary meeting of its shareholders, currently scheduled for January 24. The agenda for the meeting includes a proposed election of a new external director who is expected to become a member of the company's audit committee upon his election, thereby enabling the company to regain compliance with the NYSE audit committee composition requirements.

16:32 EDT Gannett says Chief Product Officer Kris Barton to assume expanded role - Gannett announced that Kris Barton, Chief Product Officer, will now report to Robert Dickey, president and CEO, with expanded duties. Barton will continue to oversee the strategic direction and innovation of product and technologies for the company's consumer content and its business-to-business advertising and marketing solutions, including managing both SweetIQ and WordStream. Gannett announced that Kevin Gentzel, formerly Chief Revenue Officer, has been named president, USA TODAY NETWORK Marketing Solutions, effective January 26. Gentzel replaces Sharon Rowlands, who is leaving the company to pursue another opportunity.

16:32 EDT New York Mortgage names Jason Serrano president - New York Mortgage Trust announced that its board of directors has named Jason T. Serrano as president of the company, effective January 7, 2019. Serrano will report to Steven R. Mumma, the company's CEO. Serrano was a Partner at Oak Hill Advisors, L.P., an alternative investment management firm, from January 2014 to December 2018 and a Managing Director at OHA from April 2008 to December 2013. While at OHA, Serrano ran the mortgage investment business. Prior to joining OHA, Serrano served as a Principal at The Blackstone Group, where he led the structured finance investment team. Prior to Blackstone, Serrano spent five years at Fortress Investment Group as Vice President, assisting in the management of $2B of distressed structured products and whole-loan portfolios.

16:30 EDT EQT Corporation cuts staff to save $50M annually, aims for mid-single digit FCF - In an 8-K filing, EQT Corp states: "With our complex transformation successfully behind us, our team is now focused on optimizing operations and generating returns from our world-class natural gas assets. We understand that our recent operational performance was disappointing to shareholders, as it was to the EQT team. EQT can and must deliver improved financial and operational results. This team is taking aggressive, meaningful, and decisive steps to strengthen our financial position and ensure that everyone at EQT is aligned with our objectives. To that end, this morning we announced a reduction in our workforce, removing management layers, streamlining functions and reducing shared services and contractor expenses. This action, which was completed today, demonstrates our ongoing commitment to one of our key strategic priorities, reducing costs, and is expected to result in approximately $50 million in annual cash savings. In the near future, we will be announcing our 2019 plan to unlock the tremendous potential of EQT's assets. We intend to achieve mid-single digit year-over-year growth combined with meaningful free cash flow, and when we announce our 2019 capital program, we will provide additional operational and financial projections. We will also provide clear and measurable action items so that shareholders can assess our progress."

16:26 EDT CBRE Group plans to split CFO, Chief Investment Officer roles into two positions - CBRE Group announced plans to divide the responsibilities of its CFO and Chief Investment Officer into two senior executive positions. Jim Groch, who has led both financial management and capital deployment functions since early 2014, will transition to focus full-time on capital allocation and deployment. The plan to separate the senior executive positions comes as CBRE's capacity to make investments has substantially increased following nearly a decade of strong financial performance and strategic gains across the company. Based in Dallas, the new CFO position will oversee CBRE's finance and accounting organization, tax, treasury, financial planning & analytics, business intelligence and investor relations. CBRE has initiated a search for its next CFO and has retained Korn Ferry to assist in this process. Groch will continue to serve as CFO until a successor is transitioned into the role.

16:24 EDT HFF Inc. sells luxury apartment building in Chicago - HFF announced the sale of Linea, a newly constructed, 265-home, luxury high-rise apartment building located in downtown Chicago. The HFF team marketed the property on behalf of the seller. Pacific Reach purchased the offering for an undisclosed amount. Completed in mid-2017, LIinea is a 33-story tower comprising nearly 235,000 rentable residential square feet across a mix of studio through three-bedroom floor plans as well as nearly 5,000 square feet of fully occupied ground-floor retail.

16:18 EDT Pzena Investment reports preliminary AUM $33.4B at December 31, 2018 - Compared to $35.9B as of November 30, 2018.

16:18 EDT Weingarten Realty reports Q4 disposition activity of $240M - Weingarten Realty Investors announced disposition activity for the fourth quarter and full year 2018. During the fourth quarter of 2018, the Company closed $240 million of dispositions including Tropicana Beltway and Decatur 215 in Las Vegas, Nevada, Oracle Crossing and Shoppes at Parkwood Ranch in Arizona, Cherry Creek in Colorado, Seminole Towne Center in Florida, and 1919 North Loop West in Houston. The company also sold two land parcels.

16:17 EDT NCI Building CFO Shawn Poe to retire on May 31 - NCI Building Systems announced that Shawn Poe, the company's CFO has informed the board of his plans to retire from his position, effective May 31. The company will commence a search for a new Chief Financial Officer, considering both internal and external candidates.

16:10 EDT Senseonics names Jon D. Isaacson CFO - Senseonics Holdings announced the appointment of Jon D. Isaacson as the company's Chief Financial Officer, effective immediately. Concurrently, and as previously announced, R. Don Elsey has stepped down from the position and will continue in an advisory role to ensure an orderly transition and completion of the company's annual SEC filings for the 2018 fiscal year. . Most recently Isaacson served as Chief Financial Officer of Edelman Financial Services where he was responsible for financial planning and analysis, tax, treasury and corporate development.

16:07 EDT Union Pacific names Jim Vena as COO, effective January 14 - Union Pacific (UNP) named Jim Vena COO, effective January 14. He served as executive vice president and COO at Canadian National (CNI) until retiring in June 2016 after a 40-year CN career. Vena will lead all aspects of Union Pacific's operations, including Unified Plan 2020 implementation, the company's new operating plan that launched in October 2018. He will report to Lance Fritz, Union Pacific chairman, president and CEO.

16:05 EDT Spero, Everest enter into Asian license agreement - Spero Therapeutics and Everest Medicines announced that they have entered into a collaboration to develop, manufacture and commercialize SPR206 in Greater China, South Korea and certain Southeast Asian countries, along with an exclusive option to rights to SPR741 in the Territory.

16:01 EDT Saba Capital reports 5.4% passive stake in Eaton Vance Limited Duration

15:47 EDT Generex completes acquisition of 51% of Regentys - Generex Biotechnology is pleased to announce that the company has completed the acquisition of 51% of Regentys Corporation, a regenerative medicine company focused on developing novel treatments for patients with gastrointestinal, GI, disorders. The terms of the deal include the previously reported upfront payment of $400,000, plus $14.6M to be paid according to a milestone-based schedule. Rick Bulman, CEO of Regentys(TM) continued, "Our partnership with Generex provides Regentys with a number of advantages, and we are happy to join the NuGenerex family of subsidiary companies. The merger agreement offers not only the financing to advance our clinical development efforts, but the Generex corporate philosophy also promotes continuity by supporting our scientific, medical, and leadership team with resources, relationships and industry knowledge that will accelerate the commercial introduction of Regentys ECMH."

15:22 EDT Qualcomm to showcase in-vehicle capabilities featuring Amazon Alexa at CES - Qualcomm Technologies, a subsidiary of Qualcomm Incorporated (QCOM), announced plans to showcase artificial-intelligence intuitive in-vehicle experiences for next generation vehicles during the Consumer Electronic Show 2019. "Utilizing the natural language processing and speech recognition capabilities offered by Amazon Alexa, Qualcomm Technologies plans to exhibit how the capabilities of highly intuitive voice-based experiences, such as in-car virtual assistance and natural interactions between the vehicle and driver, can transform in-vehicle experiences for next generation vehicles. Qualcomm Technologies will also feature Amazon Music, Prime Video, Fire TV and Audible services as a part of the in-vehicle demonstration," the company stated.

15:17 EDT Eli Lilly, Loxo deal includes $265M termination fee under some circumstances - In a regulatory filing, Eli Lilly (LLY) and Loxo Oncology (LOXO) disclosed that their agreement and plan of merger contains termination rights for each of the companies, including by either Lilly or Loxo if the offer closing time shall not have occurred on or before July 5, 2019, or by Loxo to enter into an alternative transaction that constitutes a "Superior Company Proposal," and further provides that upon termination of the merger agreement under specified circumstances Loxo may be required to pay Eli Lilly a termination fee of $265M.

15:04 EDT Meredith names Catherine Levene as Chief Strategy Officer - Meredith announced that Catherine Levene has been named Chief Strategy Officer. She will begin her new duties on January 14.

14:51 EDT Nvidia jumps over 6% after announcing RTX 2060 for gamers - Nvidia unveiled on Sunday, the Nvidia GeForce(R) RTX 2060. "The RTX 2060 GPU delivers exceptional performance on modern games, with graphics enhanced by ray tracing and AI capabilities. Priced at $349, RTX 2060 delivers new levels of performance and features previously available only in high-end gaming GPUs," said the company in a statement. The RTX 2060 is 60 percent faster on current titles than the prior-generation GTX 1060, Nvidia's most popular GPU, and beats the gameplay of the GeForce GTX 1070 Ti. With Turing's RT Cores and Tensor Cores, it can run Battlefield V with ray tracing at 60 frames per second. The RTX 2060 will be available globally starting Jan. 15 from every major OEM, system builder and graphics card partner. "Next-gen gaming starts today for tens of millions of gamers everywhere," saidNvidia founder and CEO Jensen Huang, who unveiled the RTX 2060 at the start of the CES tradeshow. "Desktop gamers are demanding, and the RTX 2060 sets a new standard - an unbeatable price, extraordinary performance and real-time ray tracing that blurs the distinction between movies and games. This is a great moment for gamers and our industry." Shares of Nvidia are up 6% or $8.20 per share to $144.37 per share.

14:21 EDT Avis Budget and connected mobility firm Continental expand partnership - Avis Budget and Continental announced that they have expanded their partnership. Under the enhanced collaboration, Avis Budget Group will boost its fleet of connected cars in the United States and Europe by equipping 50,000 vehicles with Continental's enhanced Key as a Service, KaaS, technology. Continental's enhanced KaaS solution allows for two-way data communication between a vehicle and Avis Budget Group's cloud-based system and its Avis mobile app, which effectively "connects" the car. Connected vehicles empower Avis customers to manage their entire rental experience through the Avis mobile app. In addition, Continental's aftermarket solution also eliminates the need for physical car keys and enables Avis customers to use the Avis mobile app to unlock the car and start the engine. Until now, the KaaS solution only allowed for keyless entry and ignition and was only available in the greater Kansas City, Missouri area as part of Avis Budget Group's "Mobility Lab" which serves as a test bed for fully connected vehicles and operations. "Continental's technology coupled with the Avis mobile app is another way that we are reinventing rental by making the overall customer journey more convenient, transparent, personalized and seamless," said Arthur Orduna, executive vice president and chief innovation officer, Avis Budget Group. "We're delighted to build upon the success of our KaaS pilot in the Kansas City area, and provide customers in other markets and countries with mobility on demand where and when they need it. Now, we're another step closer to our goal of a fully connected fleet by the end of 2020."

14:16 EDT Air Products to build second California liquid hydrogen production facility - Air Products announced plans to build a second liquid hydrogen production facility in California to meet increasing product demand from several customer markets, including the growing fleet of hydrogen fuel cell vehicles in the state. Project development work is already underway with an anticipated facility onstream during the first quarter of 2021, the company said.

13:58 EDT Harley-Davidson announces pricing, availability for electric production cycle - Harley-Davidson revealed two new concept electric two-wheelers and announced pricing and pre-order availability for LiveWire, its first electric production motorcycle. The 2020 LiveWire is now available for U.S. dealer pre-order, with deliveries expected this fall and select global markets announced at a later date. The LiveWire motorcycle has a U.S. MSRP of $29,799, the company stated.

13:22 EDT Icahn says nearly 100% hedged, doesn't know 'what market will do' - Carl Icahn is speaking on Fox Business.

13:08 EDT Visa, Sirius XM partner for new in-vehicle payment solution - Visa (V) and SiriusXM Connected Vehicles Services (SIRI) announced at the Consumer Telematics Show in Las Vegas their plan to revolutionize the driving experience with a new in-vehicle payment solution. Visa and SiriusXM are working to enhance the way customers spend their time in-vehicle and plan to offer the SiriusXM e-wallet to manufacturers who deploy SiriusXM's connected vehicle services, the broadly adopted connected vehicle platform in North America, serving multiple major automotive brands. The SiriusXM e-wallet is being designed to integrate into the dashboard and will allow drivers and their passengers to complete and make purchases for everyday tasks on-the-go: shop and pay for coffee, find and pre-pay for gas, locate and pay for parking, purchase movie tickets, seamlessly pay tolls, and more. Users will activate and authenticate payment with their Visa account using biometric authentication, like voice and touchscreen commands, to eliminate driver distractions during the transaction. Powered by Visa and SiriusXM application programming interfaces, the solution can draw on a range of technologies to enable safer and more secure commerce, including the Visa Token Service, which allows an extra layer of security for payments. To implement these services, Visa is establishing virtual payment relationships through its wide-ranging network of retailers and providing secure authentication capabilities for added security, while SiriusXM is developing the next-generation protocols needed to establish real-time connectivity and in-vehicle interfaces with a broad variety of personalized content and data aggregated from a network of platforms.

13:06 EDT Icahn says Trump 'has done a good job in many areas' - Carl Icahn is speaking on Fox Business.

13:03 EDT Icahn says 'mandatory' U.S. does trade deal with China - Carl Icahn is speaking on Fox Business.

12:38 EDT Theravance to reduce overall headcount by approximately 50 individuals - Theravance Biopharma (TBPH) announced a reduction in workforce to align with its focus on continued execution of key strategic programs, and advancement of selected late-stage research programs toward clinical development. Theravance Biopharma will reduce its overall headcount by approximately 50 individuals, with affected employees primarily focused on early research or the infrastructure in support of VIBATIV. VIBATIV is a marketed antibiotic recently sold by the company to Cumberland Pharmaceuticals (CPIX). "Our portfolio has evolved over time, most recently with the approval and commercial launch of YUPELRI plus the advancement of TD-1473 and ampreloxetine into late-stage development programs. At this juncture, we concluded it was prudent to focus resources on our late-stage research projects and translational science, late-stage development pipeline, and the commercialization of YUPELRI," said Rick E Winningham, chairman and CEO of Theravance Biopharma. "While we are scaling back our activities in early research, we remain committed to drug discovery as a source of future long-term growth for our organization. In 2019, those efforts will include driving four new, promising organ-selective projects toward first-in-human studies. We want to express our deep appreciation to the employees who are leaving for their significant contribution to the company's achievements, and we wish them well in their future endeavors."

12:08 EDT BMO Financial Group announces new financial crimes unit headed by Larry Zelvin - BMO Financial Group announced that it will create a Financial Crimes Unit to be led by Larry Zelvin, who joins the bank effective January 14, 2019. The Financial Crimes Unit brings together existing capabilities around cybersecurity, fraud, and physical security from across the enterprise into an integrated central function. As head of the Financial Crimes Unit, Zelvin will be responsible for defining and executing strategy, mobilizing stakeholders, and working in full coordination with businesses across the bank.

12:06 EDT Daimler Trucks invests EUR500M in highly automated trucks - At the Consumer Electronics Show in Las Vegas, Daimler Trucks announced that it will invest EUR 500M, or about $570M, over the next years and create more than 200 new jobs in its global push to bring highly automated trucks to the road within a decade. Highly automated driving is characterized as automated travel in defined areas and between defined hubs without any expectation of the system that a user will respond to a request to intervene. The new Freightliner Cascadia offers partially automated driving features, making it the first-ever partially automated series production truck on North American roads. Daimler Trucks is creating 200 new jobs in the area of highly automated driving. The newly created positions and roles are to be filled primarily by mechatronics engineers or robotics specialists with IT and programming skills. The main location is Daimler Trucks & Buses new Automated Truck Research & Development Center in Portland.

12:02 EDT EDF Renewables North America, Phoenix Wind Repower sign O&M agreement - EDF Renewables North America has signed a multi-year agreement with Phoenix Wind Repower, a portfolio investment of a fund managed by the Infrastructure and Power strategy at Ares Management Corporation, to provide operations and maintenance services for three wind projects located in Texas. With this agreement, EDF Renewables' Asset Optimization portfolio has reached over 2,300 megawatts in Texas encompassing 15 projects and six turbine manufacturers. Under the terms of the agreement, EDF Renewables will provide Asset Management, Balance of Plant Management, Remote Monitoring, and NERC Compliance Services for the wind projects. Trinity Hills, Sherbino Mesa II, and Silver Star projects currently operate with Clipper C96-2.5 machines and will be repowered with Vestas V110-2.2 technology by 2020.

12:00 EDT BioMarin says decision to submit valoctocogene roxaparvovec BLA tracking for 2H - BioMarin Pharmaceutical provided highlights to the investment community on its key milestones for 2019 at the 37th Annual J.P. Morgan Healthcare Conference, with Chairman and CEO Jean-Jacques Bienaime stating, "With multiple development and regulatory milestones expected in 2019, BioMarin maintains strong pipeline momentum. We are looking forward to advancing multiple product candidates in parallel through the development process. Our focus on the unmet needs in rare genetic diseases and demonstrating meaningful clinical benefits provides the foundation to move rapidly through product development and commercialization." Bienaime provided information on the company's development program for valoctocogene roxaparvovec gene therapy for severe hemophilia A. BioMarin has completed enrollment of the initial cohort of patients in its Phase 3 program intended to support a BLA submission through the accelerated approval pathway. A decision to submit a BLA through an accelerated approval pathway is tracking for the second half of 2019. If the company submits a BLA using the accelerated approval pathway, it will disclose additional information on the timing of its plans regarding the BLA submission. The complete Phase 3 study is targeting enrollment of 130 patients by mid-year 2019. BioMarin also provided an update on its clinical program for vosoritide, an analog of C-type Natriuretic Peptide, in children with achondroplasia. BioMarin expects top line results from the fully enrolled Phase 3 study of vosoritide in children by year end 2019. The Phase 2 study in infants and young children up to age 5 with achondroplasia study enrollment is on track, and in this early part of the study, vosoritide is generally well-tolerated.

12:00 EDT Hi-Crush Partners falls -16.2% - Hi-Crush Partners is down -16.2%, or -70c to $3.63.

12:00 EDT Lannett rises 17.3% - Lannett is up 17.3%, or $1.05 to $7.12.

12:00 EDT Luxoft rises 81.1% - Luxoft is up 81.1%, or $25.70 to $57.40.

11:27 EDT B Communications Ltd. trading resumes

11:18 EDT Vitamin Shoppe names Andrew Laudato CTO - Vitamin Shoppe (VSI) announced that Andrew Laudato has joined The Vitamin Shoppe as EVP, chief technology officer effective immediately. Laudato brings to The Vitamin Shoppe over two decades of experience and will have responsibility for Information Technology, Enterprise Project Planning as well as Supply Chain. For the past two years, Laudato was chief information officer at Brookdale Senior Living (BKD) where he was a member of the executive leadership team with responsibility for all aspects of technology including back office, sales and marketing among other areas.

11:01 EDT ON Semiconductor, 3M collaborate to improve roadway safety - ON Semiconductor (ON) and 3M (MMM) have jointly announced a collaboration to improve communication between vehicles and roadway infrastructure. Together, ON Semiconductor and 3M combine decades of image sensing technology and roadway safety experience, to help improve navigation for vehicles equipped with automated driving features.During CES 2019 in Las Vegas, Nevada, the two companies will display ON Semiconductor's AR0234AT CMOS image sensor integrated with 3M's next generation digitally-enabled Smart Code sign technology in the ON Semiconductor demo room at the Venetian, Level 3, Murano 3302 & 3303. Through this collaboration, both companies anticipate accelerated progress toward the next generation of infrastructure solutions to facilitate advancement in connected and automated vehicle technology.

10:31 EDT SMAAASH Entertainment changes name to Simplicity Esports and Gaming Company - SMAAASH Entertainment (SMSH) announced it has changed its name to Simplicity Esports and Gaming Company as a result of the previously announced business combination with Simplicity Esports. The company's common stock and warrants will begin trading on NASDAQ under the ticker "WINR" and "WINRW," respectively, on January 8, 2019.

10:08 EDT Trump says 'failing' New York Times story on Syria intent 'very inaccurate' - President Donald Trump tweeted: "The Failing New York Times has knowingly written a very inaccurate story on my intentions on Syria. No different from my original statements, we will be leaving at a proper pace while at the same time continuing to fight ISIS and doing all else that is prudent and necessary!....." Reference Link

10:02 EDT Meredith to launch Meredith Innovation Group, Meredith Product Studio - Meredith Corporation is launching Meredith Innovation Group, the company's new business unit focused on innovation and consumer product development which includes Meredith Product Studio, as well as new consumer products, such as Meredith Voice Network and Meredith Smart Codes, at the Consumer Electronics Show in Las Vegas this week. "Meredith Product Studio brings together the company's first-party data and insights, editorial authority, retail prowess and creative expertise to help partners rapidly design and develop innovative direct-to-consumer products. The Meredith Product Studio rapidly iterates design and creative concepts with The Foundry, Meredith's in-house creative and content agency, enabling brand partners to reach new markets and achieve growth with new products. Meredith Voice Network bundles a portfolio of voice and audio experiences based on Meredith's premium editorial content and consumer utilities for advertisers. Meredith Voice Network captures the fast-growing audience for voice experiences across Meredith's more than 40 websites, social media and leading podcast platforms, as well as voice assistants, such as Amazon Alexa and Google Assistant. Meredith Smart Codes apply QR code technology to enable readers to use their smartphones to scan magazine pages across the Meredith portfolio and connect to a wide range of digital experiences while generating enhanced ad performance and attribution data for advertisers."

10:00 EDT Hi-Crush Partners falls -16.2% - Hi-Crush Partners is down -16.2%, or -70c to $3.63.

10:00 EDT PermRock Royalty Trust rises 12.7% - PermRock Royalty Trust is up 12.7%, or $1.16 to $10.27.

10:00 EDT Luxoft rises 81.7% - Luxoft is up 81.7%, or $25.91 to $57.61.

09:53 EDT Stemline announces submission of European MAA for ELZONRIS - Stemline Therapeutics announced that it has submitted the marketing authorization application for ELZONRIS to the European Medicines Agency. The MAA seeks approval for treating patients with blastic plasmacytoid dendritic cell neoplasm. In November 2018, the EMA granted the ELZONRIS MAA accelerated assessment. On December 21, 2018, ELZONRIS was approved by the U.S. Food and Drug Administration for the treatment of BPDCN in adult and pediatric patients, two years and older, in both treatment-naive and previously-treated populations. ELZONRIS is the first treatment approved for BPDCN and the first approved CD123-targeted therapy.

09:36 EDT HealthEquity announces FY19 sales presentation - HealthEquity announced growth in its health plan with administrator network partners and employers served, and provided estimates of HSA members and custodial assets for its fiscal year ending on January 31. The number of HealthEquity health plan / administrator network partners has reached 140, up from 124 last year. The number of employers served by HealthEquity increased to approximately 45,000 up from approximately 40,000 last year. The company estimates that HSA members will grow to approximately 3.9M by January 31, up from 3.4M a year earlier. The company estimates that custodial assets will grow to between $7.7B-$7.9B by January 31, up from $6.8B a year earlier, excluding the potential impact from market volatility for the remainder of the month.

09:32 EDT Navios Maritime Partners announces $50M unit repurchase program - Navios Maritime Partners announced that its board has authorized a unit repurchase program for up to $50M of the company's common units over a two-year period. Unit repurchases will be made from time to time for cash in open market transactions at prevailing market prices or in privately negotiated transactions. The timing and amount of repurchases under the program will be determined by Navios Partners' management based upon market conditions and other factors.

09:30 EDT Taiwan Liposome Company Ltd (ADS) trading halted, volatility trading pause

09:29 EDT Eli Lilly says will continue to look in oncology for deals - Says will also look in other therapeutic areas for M&A.

09:26 EDT Alphatec COO Terry Rich resigns - Alphatec announced that Terry Rich has resigned as president, COO, and as a member of the ATEC board. Jeff Rydin, a member of the ATEC board, will assume interim leadership of the company's sales organization, while CEO Pat Miles will assume Rich's operations responsibilities in a combined role as president and CEO.

09:25 EDT Radius Health says FY Tymlos U.S. sales surpassed upper range of $95M-$98M - Radius Health announced that it has exceeded its 2018 financial guidance with full-year TYMLOS U.S. net sales surpassing the upper range of $95M-$98M. Radius closed 2018 with a $235M cash, cash equivalents and investments balance achieving its year-end guidance to be above $220M. In 2018, TYMLOS captured on average 20% of the U.S. anabolic osteoporosis market and exited the year with a 27% total U.S. anabolic market share and 40% share of new anabolic patient starts in December. TYMLOS is currently the only promoted anabolic drug in the U.S. market and is consistently increasing its prescriber base. A 5.9% price increase for TYMLOS took effect on January 1, 2019.

09:22 EDT Cerner expands relationship with Sharp HealthCare - Sharp HealthCare has expanded its relationship with Cerner, a global leader in health care technology, with the goal to enhance care delivery throughout its regional health system. Additional solutions and services will help further connect data across the health system to inform treatment decisions and care. It will also help Sharp stay up to date on the latest in health IT, with Cerner's latest solutions and services available for clinicians as they provide care. Sharp has expanded the relationship with Cerner through access to additional solutions and services to support a connected health system and help clinicians improve patient health outcomes. As part of the expanded relationship, Sharp's independent physician association, Sharp Community Medical Group, will work with Cerner to improve the overall health of members of the community with a population health management strategy and solutions. Sharp's approach will be powered by Cerner HealtheIntent, the big data and insights platform for population health management that analyzes medical data and supports clinicians in achieving actionable insights to help engage people beyond the hospital setting and manage health outcomes.

09:19 EDT Pain Therapeutics announces two publications on Remoxy - Pain Therapeutics announced two new publications for its drug candidate, Remoxy. The studies are published in Journal of Opioid Management. Remoxy is the trade name for a new type of abuse-deterrent, twice-daily capsule gel formulation of oxycodone. Remoxy has physical/chemical properties intended to deter abuse. The first publication examined the complexity, time and effort needed to extract oxycodone in a lab setting. The publication concludes that Remoxy demonstrated robust, meaningful abuse-deterrence relative to OxyContin ER and Xtampza ER. Specifically, in lab simulations of injection abuse, OxyContin ER released 65%-87% of its oxycodone within 10 minutes. Xtampza ER released 96% of its oxycodone within 5 minutes in a simple heated manipulation and released 50%-60% in two unheated manipulations in 10 minutes. In contrast, a minimal amount of oxycodone was extracted from Remoxy in heated or unheated manipulations in 10 minutes, even with the use of multistep manipulations. Additionally, in lab simulations of oral abuse, OxyContin ER released 77%-85% of its oxycodone in 5 minutes in four common ingestible liquids. In contrast, manipulated Remoxy released 2%-22% of its oxycodone in 20 minutes in five common ingestible liquids. Failure of the Remoxy formulation occurred only following a complex combination of manipulation techniques and extraction conditions that require advanced lab equipment. The second publication is titled and examined nasal abuse. The publication concludes that Remoxy demonstrated significantly lower nasal abuse potential compared to oxycodone immediate-release or OxyContin ER. Specifically, intranasal REMOXY ER led to four-fold lower peak levels of drug; a 57%-128% longer time to peak levels of drug; a greater than10-fold lower 'Abuse Quotient'; and lower 'Take Drug Again' scores compared to both OxyContin ER and oxycodone IR.

09:13 EDT Evoke Pharma announces commercial, financial agreement with NGP for Gimoti - Evoke Pharma announced a partnership with Novos Growth Partners, or NGP, to commercialize Gimoti, the company's nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis. NGP will manage the commercial operations for a dedicated sales team to market Gimoti to gastroenterologists and other targeted health care providers, if approved. NGP will also provide non-dilutive working capital for commercialization costs prior to and following product launch. The FDA has set a target goal date under the Pharmaceutical Drug User Fee Act of April 1. Under the terms of the agreement, Evoke maintains ownership of the Gimoti new drug application, or NDA. In addition, Evoke will maintain legal, regulatory and manufacturing responsibilities. Evoke will also retain a contract sales organization, which would be managed by NGP and who will finance the working capital for launch. Evoke will record sales for Gimoti and retain more than 80% of product profits. NGP will receive a percentage of product profits in the mid to high teens as a service fee once Gimoti net sales surpass commercialization costs. In addition to the non-dilutive working capital, NGP has agreed to provide up to $5M to Evoke in a line of credit following NDA approval. Evoke and NGP retain the right to terminate the agreement upon certain events, including any change of control of Evoke. The term of the agreement is five years, after which Evoke will recapture 100% of product sales and corresponding responsibilities. As of December 31, 2018, Evoke had approximately $5.3M in cash. Evoke believes this cash, the NGP working capital to cover commercialization costs and the NGP credit line, extend its cash runway into 2020 without considering any future Gimoti product revenue. Gimoti is expected to be launched in the United States during 2019, if approved by the FDA. Gimoti is under patent protection in the United States until 2030 and would be the only non-oral out-patient treatment for women suffering from diabetic gastroparesis in the United States.

09:13 EDT Ocular Therapeutix, Purdue Pharma initiate research activities - Purdue Pharma L.P. and Ocular Therapeutix announced the initiation of research activities leading to a strategic research collaboration. The goal is to determine compatibility of Purdue's non-opioid new chemical entities with Ocular's bioresorbable hydrogel-based technology, ideally leading to the development of new products for the treatment of pain. Ocular Therapeutix will initiate formulation testing, with the goal of bringing it to a stage where efficacy can be assessed. Specific terms of the agreement are not being disclosed.

09:12 EDT Fly Intel: Pre-market Movers - HIGHER: Loxo Oncology (LOXO), up 65% after agreeing to be acquired by Eli Lilly (LLY) for $235 per share... Sage Therapeutics (SAGE), up 42% after the SAGE-217 Phase 3 trial met its primary and secondary endpoints... Epizyme (EPZM), up 6% after Leerink analyst Andrew Berens upgraded the stock to Outperform from Market Perform after the company disclosed an agreement with the FDA over plans to seek accelerated approval of tazemetostat in both EZH2 mutant and wild-type follicular lymphoma as part of the same filing based on the current data set... Axsome Therapeutics (AXSM), up 188% after the Phase 2 AXS-05 trial achieved its primary endpoint... Exact Sciences (EXAS), up 8% after pre-announcing Q4 expectations. DOWN AFTER EARNINGS: Commercial Metals (CMC), down 5%. LOWER: Hi-Crush Partners (HCLP), down 20% after suspending its quarterly distribution due to market conditions... Eli Lilly, down 2% after announcing it will acquire Loxo Oncology in deal valued at $8B... British American Tobacco (BTI), down 3% after being downgraded to Market Perform from Outperform at Cowen... PG&E (PCG), down 18% after Reuters report that it is considering filing bankruptcy.

09:10 EDT Bellerophon announces results from Cohort 1 of iNO-PF trial - Bellerophon announced top-line results from Cohort 1 of the company's ongoing Phase 2b randomized, double-blind, placebo-controlled clinical study, or iNO-PF, evaluating INOpulse in patients with Pulmonary Hypertension associated with Interstitial Lung Disease, or PH-ILD. Statistically significant improvements in multiple clinically meaningful activity parameters as measured by a wearable medical-grade activity monitor were observed. Subjects on pulsed inhaled nitric oxide, or iNO, demonstrated an increase of 8% in moderate activity versus a 26% decrease for subjects on placebo. Subjects on iNO showed no decline in their overall activity levels versus a 12% decline for subjects on placebo. Wearable activity monitoring is designed to provide continuous objective real-world physical activity data and is scientifically validated to assess patient outcomes. Actigraphy is currently being utilized as the primary endpoint in multiple late-stage clinical programs in pulmonary hypertension and other cardiopulmonary diseases. Clinically meaningful improvements were also demonstrated in the following key areas. Subjects on iNO showed an increase of 15% in NT-ProBNP versus a 42% increase for subjects on placebo. NT-ProBNP is a peptide marker of right ventricular failure, with higher levels indicative of disease worsening. Subjects on iNO demonstrated improved oxygen saturation by 9% versus a worsening of 11% for placebo.In addition, iNO was well-tolerated with no safety concerns.

09:08 EDT Comtech announces contract renewal worth $1.4M - Comtech Telecommunications announced that during its second quarter of fiscal 2019, its Enterprise Technologies group, which is part of Comtech's Commercial Solutions segment, has received a renewal contract for various navigation and telematics services worth $1.4 million from a Fortune Global 500 company.

09:07 EDT Yeti appoints Melisa Goldie as CMO - YETI Holdings announced the appointment of Melisa Goldie to the newly created role of chief marketing officer, effective immediately. Goldie will report to Matt Reintjes, president and CEO of YETI. Leveraging her extensive brand strategy and marketing experience, Goldie will be responsible for crafting, articulating and driving the global brand marketing and creative vision for YETI including its direct to consumer business. She will bring together YETI's brand, creative, digital, e-commerce and customer experience teams, in order to further position the business for continued long-term growth. She previously served as the global chief marketing officer of Calvin Klein.

09:07 EDT Checkpoint Therapeutics initiates development programs for CK-301 - Checkpoint Therapeutics announced that the ongoing multi-center clinical trial of CK-301 has been expanded to enroll patients in three cohorts intended to support requests for accelerated approval and biologics license application, or BLA submissions to the FDA. These cohorts include: microsatellite instability-high endometrial cancer that has progressed following one or two prior anti-cancer therapies, microsatellite stable endometrial cancer that has progressed following one or two prior anti-cancer therapies and MSI-H or mismatch repair deficient colorectal cancer that has progressed on or after, or been intolerant of, previous treatments, including a fluoropyrimidine- and oxaliplatin- and irinotecan-based chemotherapy. Each cohort is evaluating a fixed dose of 800 mg CK-301 every two weeks. The primary endpoint for each cohort is objective response rate and secondary endpoints include duration of response, progression-free survival and overall survival. The ongoing trial is also enrolling cohorts of patients with non-small cell lung cancer and cutaneous squamous cell carcinoma.

09:05 EDT Eli Lilly says LOXO-292 most substantial component of deal - Says still working through final accounting for transaction. Says had previously contemplated some use of cash in 2019 for a deal.

09:03 EDT Roku estimates Q4 active accounts top 27M - Roku disclosed preliminary 4Q18 data for two key operating metrics, active accounts and streaming hours, demonstrating continued momentum for the Roku platform as consumers shift toward streaming and away from traditional linear TV. Q4 active accounts topped 27M, up roughly 40% year-over-year. Q4 streaming hours were an estimated 7.3B hours, up about 68% year-over-year, bringing full year 2018 streaming hours to about 24B, up about 61% from 2017. Roku will report final operating metrics as well as Q4 and FY18 financial results in February. The company will provide a 2019 outlook at that time.

09:01 EDT Eli Lilly sees no change to dividend policy as a result of Loxo deal - Eli Lilly (LLY), on its conference call discussing its proposed $8B acquisition of Loxo Oncology (LOXO), said that it sees no change to dividend policy as a result of the deal, though it will limit share repurchases in 1H. The company said it expects modest downward pressure on margins in the near-term.

08:53 EDT Hughes to supply BGAN satellite terminals for Space, Naval Warfare Systems Ctr - Hughes Network Systems, LLC (HUGHES), the global leader in broadband satellite networks and services, announced that U.S. Space and Naval Warfare Systems Center Atlantic ordered over 200 of the Hughes 9211 Broadband Global Area Network satellite terminals. Placed through Hughes partner Marshall Communications Corporation, the order outfits SSC Atlantic with the world's smallest and lightest High Data Rate terminal, enabling mission-critical military communications that are mobile and easy to deploy.

08:51 EDT Gamida Cell expects to present additional data from NAM-NK study in 1H19 - Gamida Cell expects to achieve the following milestones this year: Present additional data from the Phase 1 study of NAM-NK in first half of 2019. Report early data from the Phase 1/2 study of NiCord in patients with severe aplastic anemia data in the first half of 2019. Complete patient enrollment in the Phase 3 study of NiCord in patients with high-risk hematologic malignancies in the second half of 2019.

08:49 EDT Scientific Games selected by Oneida Indian Nation to provide sports betting - Scientific Games has been selected to provide the Oneida Indian Nation's three leading casinos in upstate New York with unrivaled sports betting player experiences through its OpenBet technology, upon the launch of New York's sports betting market. Scientific Games and Oneida will submit the agreement to the National Indian Gaming Commission for review to ensure compliance with applicable laws. It will be among the first NIGC reviews of an Indian tribe's U.S. sports betting agreement.

08:48 EDT Conduent names Rahul Gupta as Chief Technology and Product Officer - Conduent announced the appointment of Rahul Gupta as Chief Technology and Product Officer. Rahul joined Conduent in early 2017 as the leader of Conduent's Information Technology Services organization. Prior to Conduent, Rahul worked at Capgemini.

08:46 EDT Gibraltar Industries appoints William Bosway as president, CEO - Gibraltar Industries (ROCK) announced the appointment of William Bosway as president and CEO, and director, effective January 2, 2019. Bosway has been president and CEO of Dover Corporation's (DOV) Refrigeration & Food Equipment segment since June 2016. As part of the company's planned succession strategy, Frank Heard will remain employed with the company in the newly created role of vice chairman of the Board through March 3, 2020, with the principal responsibility of ensuring a smooth leadership transition.

08:44 EDT RealPage appoints Tom Ernst as CFO - RealPage announced the appointment of Tom Ernst as Executive Vice President, CFO and Treasurer. He will be based at RealPage's Richardson, Texas headquarters. Prior to joining RealPage, Ernst founded Tom Ernst Advisory in 2015.

08:43 EDT Cutera CEO James Reinstein resigns, Jason Richey named interim CEO - Cutera announced the resignation of James Reinstein as president, CEO and member of its board, effective immediately. The board has appointed Cutera's COO Jason Richey, as interim CEO. The board has formed a CEO search committee that will be chaired by director Gregory Barrett. The committee will retain an external executive search firm to assist it in conducting a national search for a permanent CEO.

08:42 EDT Elliott Management offers to buy QEP Resources for $8.75 per share in cash - Elliott Management, which manages funds that have made a substantial investment in the common stock and economic equivalents of QEP Resources, released a letter outlining a proposal to acquire QEP for $8.75 per share in cash, representing a premium of 44% to the closing stock price of January 4, 2019. The letter states: I am writing to you on behalf of Elliott Associates, L.P. and Elliott International, L.P. As you are aware, Elliott has made a substantial investment in the common stock and economic equivalents of QEP Resources and is one of the largest shareholders of the company. Since the beginning of 2018, we have engaged with the board of the company and QEP's management on the best path forward for the company to maximize shareholder value. The engagement has been constructive, and the company has made significant strides to transition to a pure-play Permian company. We support the company's divestitures of the Williston and Haynesville assets, and we would like to thank Chuck and the rest of the board as we recognize that this transition has taken a lot of time and effort. Despite the progress to date, Elliott believes that QEP remains deeply undervalued in the market today. We have conducted an extensive amount of public diligence on the company and have had ongoing dialogue with the sell-side analyst community. We believe shareholders are frustrated and that a sale of the company would be the best approach to deliver maximum value to shareholders. Elliott proposes to acquire QEP for $8.75 per share in cash. The terms of this preliminary proposal are outlined below. We believe that a transaction resulting from the Proposal would provide a compelling premium for shareholders, and would be superior to the uncertainty and risks of an alternative path. Elliott looks forward to working collaboratively with the board to finalize our Proposal. Our team is ready to engage immediately and work through the steps outlined below so that we can move forward on an expedited basis. We propose to acquire 100% of the outstanding shares of QEP for $8.75 per share in an all-cash transaction. Our Proposal represents a premium of 44% over the closing stock price of January 4, 2019. This Proposal is conditioned on the closure of the Haynesville asset sale announced on November 19, 2018, but is not conditioned on the closure of the Williston asset sale announced on November 7, 2018. We expect that we would finance the Proposal and its related fees and expenses with a combination of available cash, assumption of debt, and debt financing from third-party lenders. Elliott has approximately $35 billion of capital under management and has more than adequate capital to consummate this acquisition. Given our familiarity with the company and the extensive public diligence we have conducted to date, we believe we can complete our confirmatory due diligence in an expedited manner if we are provided appropriate information and access to management. Prior to the execution of a definitive acquisition agreement, we would anticipate the following diligence work streams: (i) customary company, commercial, and financial diligence, including reviews of historical and future prospects for the business; (ii) engaging a leading accounting firm to conduct confirmatory accounting and tax review; (iii) confirmatory legal due diligence; and (iv) asset level due diligence including reserves, land and title, and environmental reviews. As a next step, we welcome the opportunity to discuss the Proposal with the company and the board and to outline why we believe the Proposal maximizes value to shareholders. We are eager to move ahead and respectfully propose that the company hire well-regarded advisors and form a strategic review committee of the Board to oversee the process with us and potentially others. We encourage the company to make the preparations necessary to immediately assemble a data room for the Permian assets. We have the ability to consummate the transaction on an accelerated basis and are prepared to enter into a confidentiality agreement and commence our due diligence review. We are confident that a value-maximizing transaction is achievable and we look forward to the opportunity to continue our dialogue with the company, incoming President and CEO Tim Cutt, and the board."

08:40 EDT AcelRx reports publication of pooled analysis analyzing sufentanil tablets - AcelRx Pharmaceuticals announced the publication of a pooled analysis in the peer reviewed journal, Pain Management, analyzing the results of AcelRx's clinical studies to assess safety of sufentanil sublingual tablets for the short-term treatment of moderate-to-severe acute pain in medically supervised settings. The objective of the safety analysis was to evaluate the pooled data from AcelRx's clinical studies of sufentanil sublingual tablets administered at 30 mcg dose equivalents over less than or equal to 72 hours for moderate-to-severe acute pain management in both postoperative and emergency room patients. Analysis included a subset of patients from SST 15 mcg studies where patients received the first two doses of SST 15 mcg within the first 20-25 min (representing a 30-mcg dose-equivalent). Overall, 804 patients were evaluated in the pooled safety analysis, including 646 that had received the active drug. Across all of the AcelRx studies, adverse events were experienced by 60.5% of patients in the SST group, and 61.4% in the placebo group. The most common treatment-related AEs experienced by patients treated with SST were nausea (28.5%), vomiting (6.5%) and headache (5.0%). Findings from the pooled analysis support that short-term (less than or equal to72 hours) administration of SST is well tolerated, with most adverse events considered mild or moderate in severity. The publication also noted the additional safety assessment measuring cognitive impairment, which AcelRx had performed in one open-label SST 30 mcg study in emergency room patients. A total of 75 patients were dosed with SST 30 mcg and evaluated predose and 1 hour postdose for cognitive impairment using the validated Six-item Screener tool. In 97.3% of the patients, the score stayed the same or improved following a dose of SST 30 mcg.

08:40 EDT Arena says etrasimon showed long-term clinical remission in Phase 2 trial - Arena Pharmaceuticals announced data from the open-label extension of the Phase 2 OASIS trial of its investigational drug candidate etrasimod, a next-generation, oral, selective sphingosine 1 phosphate receptor modulator in development for the treatment of moderate to severely active ulcerative colitis. Overall, etrasimod demonstrated durable, long-term clinical remission and was generally safe and well tolerated in this trial. This was a 34-week open-label extension evaluating the long-term safety, tolerability and efficacy of etrasimod in 118 subjects who completed the 12-week Phase 2 OASIS randomized, placebo-controlled trial. Of the 118 subjects, 105 received only 2 mg etrasimod during the OLE study regardless of previous study treatment. Key efficacy measurements included clinical response, clinical remission, and endoscopic improvement at end of treatment. Of the subjects who completed 2 mg etrasimod treatment during the OLE study, 79% achieved clinical response, 39% achieved clinical remission, and 51% had endoscopic improvement at the end of the OLE study. For OLE study completers who received 2 mg etrasimod in the original Phase 2 OASIS trial, 82% experienced clinical response, 50% were in clinical remission, and 55% had endoscopic improvement at the end of the OLE study. Etrasimod demonstrated a favorable long-term safety profile; adverse events in the OLE study were generally mild to moderate in severity and no new safety findings were noted. Impact on heart rate and atrioventricular conduction was minimal throughout the study with no discontinuations from study related to bradycardia or AV block. The Company plans to present full study results at future medical congresses.

08:37 EDT SilverSun Technologies acquires Partners in Technology for $234,000 - SilverSun Technologies announced that its wholly owned subsidiary, SWK Technologies has acquired Partners in Technology. PIT, which was founded in 1999, is a reseller of Sage Software solutions, servicing over 160 customers in the Chicago area. The company's 2018 revenue exceeded $1M and the purchase price was $234,000, including $60,000 cash and a $174,000 3-year promissory note.

08:35 EDT Fair Isaac awarded five new patents - FICO has been awarded five new patents related to fraud, artificial intelligence and advanced analytics. In total, FICO currently holds 192 US and foreign patents, and 93 pending patent applications.

08:32 EDT Elliott Management offers to buy QEP Resources for $8.75 per share in cash

08:27 EDT Equinix invests $85M to build fourth data center in Singapore - Equinix unveiled plans to expand Platform Equinix with the construction of its fourth International Business Exchange data center in Singapore, called SG4. The new facility will provide interconnection and premium data center services to help businesses with their IT transformation and cloud adoption initiatives, while also supporting the digital infrastructure of Singapore. The new $85M seven-story data center is scheduled to open in Q4 2019, offering an initial capacity of 1,400 cabinets in the first phase.

08:25 EDT Xencor regains ex-U.S. commercial rights to XmAb13676 from Novartis - Xencor (XNCR) announced it will regain rights to develop and commercialize XmAb13676, a CD20 x CD3 bispecific antibody, from Novartis (NVS) effective June 20, 2019, due to strategic pipeline reprioritization by Novartis. Xencor granted Novartis co-development and ex-U.S. commercial rights in June 2016 through a collaboration and license agreement to develop and commercialize novel bispecific antibodies, including XmAb13676 and XmAb14045, and to access Xencor's XmAb bispecific Fc and other Fc technologies. Currently XmAb13676 is being evaluated in an open-label Phase 1, multiple-dose, dose-escalation study to assess its safety, tolerability and preliminary anti-tumor activity in patients with B-cell malignancies, and initial data are expected in 2019.

08:22 EDT FlexShopper reports preliminary 2018 gross lease originations of $58.2M - FlexShopper announced that it expects to record year-over-year lease origination growth in 2018, with gross lease originations increasing 45.8% to $58.2 million from $40.0 million in 2017 and beating guidance by approximately $6 million. FlexShopper is also shared the additional following preliminary data points regarding 4th Quarter 2018 business activity: Gross lease originations increased 28.1% to $13.2 million in December 2018 from $10.3 million in December 2017.Gross lease originations increased 44.2% to $27.4 million in Q4 2018 from $19.0 million in Q4 2017. Brad Bernstein, CEO, stated, "We had a strong finish to the year with a great holiday season, soundly beating gross lease origination guidance by approximately $6 million. Our growing repeat business, optimized direct-to-consumer growth and retail channel growth have enabled us to reach a critical mass of originations that puts us on a path to profitability in 2019. Our originations provide the foundation for our next 12 months' revenues, gross profits and cash flows and thus we are well-positioned for continued growth in these key financial metrics in 2019."

08:21 EDT Forty Seven sees cash, equivalents funding operating expenses through 1H20 - As of December 31, 2018, Forty Seven had cash, cash equivalents and short-term investments of $139.0 million. Based on its current operating plans, Forty Seven expects that its cash, cash equivalents and short-term investments will fund operating expenses and capital expenditure requirements through the first half of 2020.

08:21 EDT Maxar Technologies reports failure of WorldView-4 imaging satellite - Maxar Technologies reported that its WorldView-4 satellite experienced a failure in its control moment gyros, preventing the satellite from collecting imagery due to the loss of an axis of stability. Efforts are ongoing in conjunction with its suppliers in an attempt to restore satellite functionality, but thus far these efforts have been unsuccessful. At this time, Maxar believes that WorldView-4 will likely not be recoverable and will no longer produce usable imagery. Maxar operations has put the WorldView-4 satellite in a safe configuration and will continue to monitor the satellite's location and health. The satellite was built by Lockheed Martin and the CMGs were provided by Honeywell. WorldView-4 was acquired by GeoEye prior to its merger with DigitalGlobe in 2013. It was launched in November 2016 and generated revenues of approximately $85M in fiscal year 2018. The satellite had a net book value of approximately $155M, including related assets, as of December 31, 2018. If the satellite is not recoverable, then the net book value will be written off in Q4-2018. Contingency planning and mitigation efforts are underway to assess the use of the company's other satellites and outside resources to replace imagery collected by WorldView-4 and meet as much of the existing customer commitments and obligations as possible. The company currently believes it will be able to offset $10M-$15M of the annual revenue from WorldView-4 and will work to minimize the potential impact on Maxar's financial results in future years. The WorldView-4 satellite is insured for $183M, and Maxar intends to seek full recovery for the loss of WorldView-4 under its insurance policies. The company will provide further updates on this matter as new information becomes available.

08:19 EDT National General sees Q4 to include $11M in losses from hurricane, wildfires - National General announced that it expects its fourth quarter 2018 results to include $11 million in losses from Hurricane Michael, or $9 million after-tax, and $48 million in losses from California Wildfires, or $38 million after-tax, both net of reinsurance recoverables and inclusive of the impact of reinsurance reinstatements for the California Wildfires. Total notable large losses are expected to impact the fourth quarter 2018 by $59 million, or $47 million after-tax.

08:18 EDT iCAD: Study demonstrates effectiveness of Xoft system for BC treatment - iCAD, Inc. announced the results of a long-term study conducted at Hoag Memorial Hospital Presbyterian with the Xoft Axxent Electronic Brachytherapy System for the treatment of early-stage breast cancer using intraoperative radiation therapy. With a median follow-up of 36 months, outcomes published in the Annals of Surgical Oncology showed that breast cancer recurrence rates of patients who were treated with IORT using the Xoft System were comparable to those seen in the cornerstone, randomized TARGIT-A and ELIOT trials, which evaluated IORT using different technology. To date, this study presents analysis of the largest series of early-stage breast cancers treated with IORT using the Xoft System published in a peer-reviewed journal. The prospective study, Intraoperative Radiation Therapy: A Series of 1000 Tumors, was led by Melvin J. Silverstein, MD, Medical Director of the Hoag Breast Center, Gross Family Foundation Endowed Chair in Oncoplastic Breast Surgery at Hoag, and Clinical Professor of Surgery at the Keck School of Medicine in Los Angeles, California. The study reviewed results of 1,000 early-stage breast cancers in 984 patients enrolled in a prospective trial from June 2010 to August 2017. Patients included individuals 40 years of age and older, with lymph node negative cancer and with favorable pathology. All tumors were treated with breast-conserving surgery and IORT using the Xoft System. With a median follow-up of 36 months, there have been 28 ipsilateral local recurrences, ten of which were DCIS and 18 invasive. There have been four regional nodal recurrences and one distant recurrence. There have been no breast cancer related deaths. The low recurrence and complication rates reported support the continued study of IORT in appropriately selected women with low-risk breast cancer.

08:16 EDT GAP Airports reports December traffic up 1.7% - During December 2018, total terminal passengers increased by 7.1% at the company's 13 airports, compared to the same period of the previous year. Domestic passenger traffic increased by 7.8%, while international passenger traffic increased by 6.4%.

08:15 EDT Pulse Biosciences announces 'positive' results from NPS clinical efficacy study - Pulse Biosciences announced positive results from its clinical efficacy study using proprietary Nano-Pulse Stimulation, or NPS, technology to treat patients with Sebaceous Hyperplasia, or SH, a difficult-to-treat skin condition that typically presents on the face. Initial data indicate that 221 of 222 facial SH lesions treated with NPS energy were rated as clear or mostly clear by clinical investigators 60 days post treatment. NPS is a non-thermal technology that utilizes ultra-short, nanosecond energy pulses that directly interacts with the physical structure of cells without disrupting the integrity of non-cellular tissues. This SH study builds upon previous study results showing the safety and clinically meaningful outcomes of NPS treatment to remove Seborrheic Keratosis lesions. Further, successful elimination of Sebaceous Hyperplasia lesions substantiates the unique ability of NPS to penetrate into the dermis and target deeper cellular structures, such as the sebaceous gland, without damaging the surrounding dermis. No adverse events were reported during the course of either the SH study or SK study. The Sebaceous Hyperplasia clinical study enrolled 73 patients, over the course of two months, each with up to four facial lesions. Patients received one or two non-thermal NPS treatments per lesion at five prestigious centers in the U.S. The study's primary success measurement was the degree of clearing of benign SH lesions as rated by the investigator at the final study visit. Since these lesions frequently appear on the face, another important outcome assessment was the return of the skin's normal appearance after the lesion was removed. 99.5% of the treated lesions were assessed as clear or mostly clear by investigators at the 60-day post-treatment follow-up evaluation. Approximately 92% of treated lesions were assessed as clear or mostly clear after a single NPS treatment. Patients rated 78% of lesion outcomes at study end as satisfied or mostly satisfied. In some cases, mild to moderate post-treatment hyperpigmentation was noted, particularly in patients with higher Fitzpatrick Skin Types.

08:14 EDT Immutep enters collaboration, supply agreement with CYTLIMIC - Immutep announced that it has entered into a clinical trial collaboration agreement, a supply agreement and a service agreement with CYTLIMIC for its lead product candidate eftilagimod alpha as part of a cancer vaccine. The agreements enable the two parties to collaborate on clinical trials to evaluate efti as part of a therapeutic cancer vaccine containing CYTLIMIC's innovative cancer peptide vaccine, called CYT001. The trials will be conducted by and are under the control of CYTLIMIC who will fully fund all development costs. Under the collaboration agreement, Immutep will receive an upfront payment of $500,000 and is eligible to receive up to $4.5M in milestone payments upon the achievement of milestones by CYTLIMIC. This therapeutic cancer vaccine with efti is the third example wherein efti is being evaluated in clinical studies in a combination. In addition to the collaboration agreement, Immutep has entered into a supply agreement to provide efti to CYTLIMIC for the manufacture of CYT001 for use in the clinical development and commercialisation of the vaccine. The Parties have also entered into a service agreement where Immutep will provide technical support services to CYTLIMIC during the development and commercialisation of CYT001.

08:13 EDT Bluebird Bio announces license agreement with Inhibrx - bluebird bio announced that they have entered into an exclusive license agreement to research, develop and commercialize chimeric antigen receptor, or CAR, T cell therapies using Inhibrx's proprietary single domain antibody, or sdAb, platform to multiple cancer targets. The small size of sdAbs may enable the generation of more complex CAR T cell products such as those designed to combine additional functions into a single CAR molecule or recognize multiple tumor antigens simultaneously. Under the terms of the license agreement, Inhibrx will provide bluebird bio the exclusive worldwide rights to develop, manufacture and commercialize certain cell therapy products containing sdAbs directed to various cancer targets. bluebird bio will be responsible for the clinical development and commercialization of the cancer-targeting CAR-T products. Inhibrx received a $7M upfront payment and is also entitled to receive specified developmental milestone payments as well as percentage tiered royalties on future product sales.

08:10 EDT Immutep enters into clinical trial collaboration agreement with Cytlimic - Immutep Limited announced that it has entered into a clinical trial collaboration agreement, a supply agreement and a service agreement with CYTLIMIC Inc. for its lead product candidate eftilagimod alpha as part of a cancer vaccine. The agreements enable the two parties to collaborate on clinical trials to evaluate efti as part of a therapeutic cancer vaccine containing CYTLIMIC's innovative cancer peptide vaccine, called CYT001. The trials will be conducted by and are under the control of CYTLIMIC who will fully fund all development costs. Under the collaboration agreement, Immutep will receive an upfront payment of $500,000 and is eligible to receive up to $4.5M in milestone payments upon the achievement of milestones by CYTLIMIC.

08:09 EDT Alnylam announces unaudited Q4 ONPATTRO revenues of $11M-$12M - Alnylam Pharmaceuticals pre-announced its unaudited fourth quarter 2018 global net product revenues for ONPATTRO and provided additional updates on the product's commercial launch. ONPATTRO global net product revenues for the fourth quarter of 2018 were $11M-12M. As of year-end 2018, over 200 patients in the U.S. and EU were receiving commercial ONPATTRO treatment, and approximately 550 total patients worldwide, including patients on commercial drug and patients in clinical studies and in the Company's global Expanded Access Program, were being treated with patisiran. In the U.S., a total of 250 Start Forms were submitted as of year-end 2018. Of these, approximately 50% were from patients previously treated on the ONPATTRO EAP. The Start Forms came from a diverse range of prescribing physician specialties, including 44% neurologists, 35% cardiologists, and 21% from other specialties. For Start Forms received, 62% of patients were covered by Medicare, 32% were covered by commercial insurers, and 6% were covered by other government insurers. Significant progress has been made with value-based agreements in the U.S. and with market access efforts in the EU. Since launch, Alnylam has completed full VBAs with Harvard Pilgrim Healthcare, Humana, and another top five U.S. payer. Additional VBAs are under negotiation with over 15 other commercial payers with the potential to cover over 90% of commercial lives in the U.S. In addition, the Company today reported that at December 31, 2018, it had cash, cash equivalents and marketable debt securities, and restricted investments, excluding equity securities, of approximately $1.1B. The Company intends to provide 2019 financial guidance on non-GAAP R&D and SG&A expenses and year-end cash balance in connection with its full, audited fourth quarter and year-end 2018 financial results in February 2019.

08:08 EDT Natera announces publication of kidney transplant validation study - Natera announced clinical validation study results published in the Journal of Clinical Medicine, demonstrating the highly accurate performance of its donor-derived cell-free DNA test for active allograft rejection in kidney transplant recipients, including higher sensitivity and nearly 18% higher area under the curve than the competitive dd-cfDNA assay.1,2 The study also reports the first accurate detection of T-cell mediated rejection and subclinical rejection. This marks the successful completion of all 2018 commercialization milestones, and is in line with the company's plan to secure Medicare coverage and commercially launch its test in 2019. The blinded study, conducted in collaboration with the University of California, San Francisco (UCSF), leveraged Natera's massively-multiplexed PCR (mmPCR) technology to measure dd-cfDNA levels in plasma collected on the same day as a kidney biopsy from 193 unique kidney transplant recipients. The primary analysis focused on 217 plasma samples from 178 unique kidney transplant patients, including 38 cases of histologically-confirmed active rejection, making it the largest published study of its kind, with approximately two times more patients and 40% more affected cases of AR than the next largest study. Another strength of the study is its broad ethnic diversity, which is important because kidney transplant assessment and biomarker performance are known to vary by ethnicity. In the study, Natera's assay detected AR with 89% sensitivity and 0.87 AUC. This test performance compared favorably to the current standard of care, eGFR, which is a clinically accepted but inaccurate biomarker for AR. The study results also showed higher sensitivity (89% vs. 59%) and higher AUC (0.87 vs. 0.74) than the competitive dd-cfDNA assay. This superior data may be due to differences in the analytical performance and underlying technology behind the assays.

08:07 EDT MarketAxess appoints Chris Concannon COO - MarketAxess announced the appointment of Chris Concannon, a veteran exchange industry executive, as president and COO, effective as of January 22. In this role, Concannon will oversee day-to-day operations, corporate development, long-term technology strategy and global data strategy, reporting to Rick McVey, CEO of MarketAxess. He will also join the board, with a particular focus on the company's corporate strategy. Concannon joins MarketAxess from Cboe Global Markets where he served as president and COO. He came to the Cboe in 2017 as part of its acquisition of Bats Global Markets, where he was CEO. Concannon was responsible for Cboe's transaction businesses as well as overseeing the company's technology, operations, risk and marketing divisions.

08:06 EDT Second Sight announces $40M rights offering of units - Second Sight Medical Products announced a rights offering to raise $40 million. Second Sight plans to use the proceeds from the rights offering to: (i) continue gathering clinical and performance data to support safety and efficacy of Orion; (ii) complete ongoing development of Argus 2s, the Company's next-generation externals and seek regulatory approvals; (iii) advance research in areas such as eye-tracking and object recognition; and (iv) for other operating and general corporate purposes. The Company has agreed to extend the term of the warrants from March 14, 2022 through March 14, 2024 if the rights offering provides gross proceeds of at least $20 million, and if that amount is not obtained the original expiration date of the warrants will remain unchanged. Gregg Williams, Chairman of the Board, has indicated his non-binding intention to participate in the rights offering in an amount of up to $20 million.

08:04 EDT CACI awarded potential $125M task order for the U.S. Navy's MSC - CACI International announced that it has been awarded a potential $125M task order to support integrated business systems for the U.S. Navy's Military Sealift Command. This five-year contract, awarded under the CIO-SP3 contract vehicle, represents both new and continuing work in CACI's Logistics and Material Readiness market area.

07:51 EDT Diplomat Pharmacy partners with CSI Specialty Group - Diplomat Pharmacy and CSI Specialty Group have launched a program for hospitals and health systems interested in starting or expanding their own specialty pharmacy services to benefit from Diplomat's limited-distribution drug portfolio and expertise treating rare, chronic, and complex diseases.

07:47 EDT Allergan: 'Positive' 3-month results from second Phase 3 study of Bimatoprost SR - Allergan announced positive 3-month topline results from the second pivotal clinical trial of Bimatoprost SR, a first-in-class sustained-release, biodegradable implant for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension. Positive results from the first Phase 3 trial were reported in June 2018. Bimatoprost SR is designed to lower IOP for at least 4 months, achieving clinical goals while freeing patients from daily eye drop regimens. Allergan anticipates submitting a New Drug Application to the FDA in the second half of 2019. Allergan is also conducting Bimatoprost SR clinical trials for registration outside the United States which are ongoing. In this Phase 3 clinical study of 528 subjects with open-angle glaucoma or ocular hypertension, Bimatoprost SR reduced IOP by approximately 30% over the 12-week primary efficacy period, meeting the predefined criteria for non-inferiority to the study comparator, timolol. Results of this second Phase 3 study with an identical design as the first study, showed that the magnitude of IOP-lowering efficacy with Bimatoprost SR is similar to that observed with topical prostaglandin analogues. "The data results of intracameral Bimatoprost SR were consistently demonstrated in two pivotal trials, highlighting the sustained, predictable and potentially sight-saving benefits of this exciting new approach in treating patients with glaucoma," said David Nicholson, Chief Research and Development Officer, Allergan. "We are particularly encouraged by the long-term efficacy results leading to an extended treatment-free period." The study also showed the potential for the vast majority of patients to remain treatment free for at least 1 year after the last implant was inserted. Overall, Bimatoprost SR was well tolerated in the majority of patients. The 20-month masked study is ongoing, and additional data will become available as patients complete the study.

07:43 EDT Primoris announces $31M power award with California power operator - Primoris announced a new power award valued over $31M with a California power operator. The contract was secured by ARB Industrial. The award is for the construction of a 98 MW power generation facility located in Southern California. ARB Industrial's scope of work includes installing two new gas turbines at the facility, whose final configuration will include a 10-megawatt integrated battery storage component to complement the gas turbines. Work is scheduled to commence in Q1 and completion is expected in Q4.

07:41 EDT KemPharm announces FDA approval of Apadaz sNDA for two additional strengths - KemPharm announced today that the FDA has approved a supplemental new drug application, or sNDA, for two additional strengths of Apadaz, an immediate release combination of KemPharm's prodrug, benzhydrocodone, and acetaminophen, or APAP. The approval of these new dosage strengths, 4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP, follows the NDA approval on February 23, 2018 of the 6.12 mg benzhydrocodone/325 mg APAP dosage strength of Apadaz.

07:39 EDT Adaptimmune announces SRC endorsement for dose escalation in ADP-A2AFP study - Adaptimmune announced that the Safety Review Committee, or SRC, has endorsed dose escalation in the ongoing ADP-A2AFP study in patients with hepatocellular carcinoma to the second dose cohort. The SRC has also endorsed moving to the expansion phase of the ADP-A2M10 lung cancer study. Across both studies, most adverse events have been consistent with those typically experienced by cancer patients undergoing cytotoxic chemotherapy or other cancer immunotherapies with no evidence of alloreactivity or toxicity related to off-target binding. In the ADP-A2AFP study, two patients have received 100M transduced SPEAR T-cells targeting AFP in the first dose cohort, and there was no evidence of hepatotoxicity. The SRC endorsed dose escalation after evaluating the first two patients and taking into consideration the benefit:risk profile observed across programs in Cohort 1. In the ADP-A2M10 lung cancer study, ten patients have been treated in the first three cohorts and the expansion phase will allow for doses of up to 10B transduced cells.

07:37 EDT Allergan to establish R&D presence in Cambridge, Massachusetts - Allergan announced it will establish an R&D presence in the Kendall Square section of Cambridge, Massachusetts, a hub of science, innovation and business opportunities. The site will be led by Don Frail, PhD, Senior Vice President of Research and External Scientific Innovation and Non-Clinical and Translational Sciences.

07:36 EDT Spero Therapeutics reports 'positive' feedback from FDA pre-Phase 3 meeting - Spero Therapeutics announced the results of its Type B / pre-IND / pre-Phase 3 meeting with the U.S. FDA regarding SPR994 for the oral treatment of complicated urinary tract infections. Based on its discussions with the FDA, Spero believes that positive results from a single pivotal Phase 3 clinical trial of SPR994 in cUTI demonstrating a 10% non-inferiority margin would support the approval of SPR994 for the treatment of cUTI. As a result of the meeting, Spero has submitted an Investigational New Drug application for SPR994 in cUTI with the FDA and begun startup activities for its ADAPT-PO Phase 3 clinical trial as well as ancillary supportive studies required for the approval of SPR994. The Company anticipates opening trial sites to support study enrollment in the first quarter of 2019. Spero's planned pivotal Phase 3 clinical trial of SPR994, ADAPT-PO, is designed as a double-blind, double-dummy trial to compare oral SPR994 with an existing standard of care intravenous (IV) antibiotic, ertapenem, in approximately 1,200 patients randomized 1:1 in each arm. As currently planned, the primary endpoint of the pivotal trial will be the combined clinical and microbiological response at the test of cure with a 10% non-inferiority margin versus IV ertapenem. The trial will incorporate a lead-in cohort of 70 patients with intensive pharmacokinetics assessment to confirm the dose and exposure in the cUTI patient population. Spero anticipates receiving interim pharmacokinetic data from the trial's lead-in cohort in the second half of 2019. In addition to the planned pivotal Phase 3 trial, Spero will conduct routine ancillary clinical pharmacology studies in parallel with the Phase 3 trial, including a renal insufficiency study, a thorough QT prolongation study and a drug-drug interaction study. Spero believes that its existing cash, cash equivalents and marketable securities as of September 30, 2018, together with initial committed funding of $15.7 million of the up to $54 million in funding awarded under its BARDA award, will fund its operations into the second half of 2020, including through top-line data readout of the planned pivotal Phase 3 clinical trial of SPR994.

07:35 EDT Arrowhead files for regulatory clearance to begin ARO-APOC3 Phase 1 study - Arrowhead Pharmaceuticals announced that it has filed an application for approval to begin a Phase 1 clinical trial of ARO-APOC3, an RNAi-based investigational medicine targeting Apolipoprotein C-III being developed for the treatment of hypertriglyceridemia. Pending approval, Arrowhead intends to proceed with AROAPOC31001, a Phase 1 single and multiple dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of ARO-APOC3 in adult healthy volunteers, hypertriglyceridemic patients, and patients with familial chylomicronemia syndrome. The study is designed to enroll up to 63 subjects.

07:35 EDT Infinity Pharmaceuticals plans to initiate MARIO-275 study in 1H19 - Infinity plans to initiate MARIO-275, a combination study of IPI-549 with Opdivo in I/O naive urothelial cancer patients, in the first half of 2019. Opdivo was approved for use by the FDA as a single agent in advanced urothelial cancer based on durable response associated with treatment in CheckMate-275, a Phase 2 single arm clinical trial of Opdivo in subjects with metastatic or unresectable urothelial cancer who have progressed or recurred following treatment with a platinum agent. Retrospective analyses of this study showed that patients with higher levels of myeloid derived suppressor cells, or MDSCs, had poor outcomes2. IPI-549 has been shown to reduce MDSCs as both a monotherapy and in combination with Opdivo in MARIO-13-6. MARIO-275 is intended to evaluate the benefit of adding IPI-549 to Opdivo in cisplatin-refractory, I/O-naive urothelial cancer patients. Clinical benefit will be assessed in the overall population as well as in subsets of patients with different baseline levels of MDSCs. Infinity will also be advancing novel triple combination therapies with Arcus, initially evaluating IPI-549 in combination with AB928, Arcus's dual adenosine receptor antagonist, and chemotherapy in patients with previously treated, advanced triple negative breast cancer, or TNBC. As both macrophages and high adenosine levels are believed to play critical roles in creating a highly immune-suppressive tumor microenvironment in cancer after chemotherapy, the novel immuno-oncology combination being evaluated in this setting represent a potentially promising approach to treating TNBC.

07:33 EDT Dollar Tree: Management welcomes constructive input from shareholders

07:33 EDT Dollar Tree comments on statement issued by Starboard Value - Dollar Tree issued the following statement regarding Starboard Value's announcement of its nomination of directors for election to the Dollar Tree Board at the company's 2019 Annual Meeting of shareholders: "Dollar Tree is focused on ensuring our brands are the premier shopping destination for value and convenience, taking the right actions to solidify our leadership position in value retail and leveraging our resilient business model, disciplined approach, clear customer focus and unique positioning to deliver growth and strengthened performance for the benefit of all stakeholders. Dollar Tree is committed to a strong, independent Board, and believes it has the right balance of perspectives and experience to drive enhanced growth and performance across the company. The Board has added four new independent directors since May 2016, including most recently last month, and benefits from a broad array of skills and perspectives spanning areas key to our business, including retail and consumer products, merchandising, strategic planning, finance, capital allocation and mergers and acquisitions. Dollar Tree's Board and management team are continuing to execute on the Company's strategy and remain focused on delivering long-term value to all shareholders. Dollar Tree's Board and management team welcome constructive input from shareholders about ways to further create value for all Dollar Tree shareholders. While we appreciate Starboard's investment and will evaluate any suggestions they may have as we would with any investor, we note that Starboard's nominations for a majority of the board were made without seeking any engagement or making any communication to the Company. We look forward to the opportunity to engage with Starboard regarding any suggestions they may have, and we will continue to stay close to our shareholders on matters of importance to them and keep taking actions to drive shareholder value. "The Board and its Nominating and Corporate Governance Committee will evaluate Starboard's nominees in the event Starboard determines to proceed with its nominations and make a recommendation in due course that it believes will best serve the interests of the Company and its shareholders." The Board will present its recommendation regarding director nominees in Dollar Tree's definitive proxy statement and other materials, to be filed with the Securities and Exchange Commission and made available to all stockholders eligible to vote at the 2019 Annual Meeting. Details regarding the 2019 Annual Meeting will be announced in due course.

07:27 EDT Hi-Crush Partners suspends quarterly distribution due to market conditions - Hi-Crush Partners announced the board's decision to suspend the quarterly distribution. Hi-Crush previously declared a quarterly cash distribution of 22.5c per unit on all common units, or 90c on an annualized basis, for Q3 of 2018, which was paid in November 2018. "As a result of the challenging conditions experienced in the fourth quarter, the Board of Directors made the decision to suspend the quarterly distribution, which reflects our commitment to financial discipline and maintaining a strong balance sheet," said CFO Laura Fulton. "Our balance sheet is well positioned for the challenges facing the industry, supported by our financial structure with no maintenance covenants, and enhanced by the Board's decision to further protect our capital position. With $114 million of cash as of year-end and no borrowings under our asset-backed facility, we have more than sufficient funding for our semi-annual interest payments, our 2019 maintenance capex and remaining growth capex from our 2018 expansion projects."

07:20 EDT Eli Lilly says no changes to 2020 operating margin goal after Loxo deal - Eli Lilly (LLY), in slides that will be presented on the company's conference call discussing its proposed $8B acquisition of Loxo Oncology (LOXO), said that it sees the deal accretive to operating margins over time. Lilly sees the potential for meaningful value contribution well into 2030s. It said it expects Loxo to be potentially accretive on a cash basis in 2022. The impact to 2019 financial guidance will be updated in its Q4 earnings announcement in February, Lilly said. In the meantime, Lilly said it is likely to limit share repurchases to $3.5B during 1H19.

07:16 EDT Akoustis reports order for 5.2 GHz BAW RF filters from WiFi SoC customer - Akoustis Technologies announced it has received a pre-production order for its 5.2 GHz XBAW filters from a leading WiFi system-on-chip company. The filters will be evaluated for a reference design targeting tri-band WiFi customer premise equipment.

07:15 EDT Cara Therapeutics completes enrollment of KALM-1 Phase 3 trial of Korsuva - Cara Therapeutics announced completion of enrollment in the KALM-1 Phase 3 trial of KORSUVA Injection in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus. More than 350 hemodialysis patients with CKD-aP have now been randomized across approximately 60 clinical sites in the United States. KALM-1 is a multicenter, randomized, double-blind, placebo-controlled 12-week treatment trial in the U.S. with a 52-week open label extension phase that is designed to evaluate the safety and efficacy of 0.5 mcg/kg KORSUVA CR845/difelikefalin injection in 350 hemodialysis patients with moderate-to-severe pruritus. The primary efficacy endpoint is the proportion of patients achieving at least a 3-point improvement from baseline in the weekly mean of the daily 24-hour Worst Itch Numeric Rating Scale score at week 12. In a completed Phase 2 trial, the proportion of patients with an improvement from baseline in the weekly mean Worst Itch NRS score of greater than or equal to3 points at week 8 was statistically significantly higher in the CR845/difelikefalin 0.5 mcg/kg group compared to the placebo group . Secondary endpoints include assessment of itch-related quality of life changes measured using the validated self-assessment 5-D itch and Skindex-10 scales, as well as the proportion of patients achieving greater than 4-point improvement from baseline in weekly mean of the daily 24-hour Worst Itch NRS score at week 12.

07:13 EDT Range Resources sees 2018 capital spending $20M below $941M budgeted - Range Resources announced that 2018 capital spending is currently estimated to be approximately $20M below the $941M budgeted for the year. The company's 2018 program was better than budget as a result of savings from a variety of sources, including drilling efficiencies and water recycling.

07:12 EDT ProQR Therapeutics announces design on ILLUMINATE trial - ProQR Therapeutics announced that it has reached agreement with the FDA on the design of a Phase 2/3 pivotal trial for QR-110, now renamed to sepofarsen, in patients with Leber's congenital amaurosis 10, or LCA10 due to the p.Cys998X mutation in the CEP290 gene. LCA is the leading genetic cause of childhood blindness. The trial is expected to start in the first half of 2019. We anticipate top line results for base-case of 30 trial participants around year-end 2020. ILLUMINATE will be a randomized, double-masked, sham-controlled trial initially enrolling 30 adults and children assigned equally to three parallel arms with 10 participants in each arm. The trial incorporates adaptive sample size re-estimation and is designed with potential to serve as the sole registration trial for the program. Participants will receive a dose of sepofarsen or a sham-injection at the start of the trial, at three months and then every six months. The primary efficacy endpoint for the trial will be change in visual acuity from baseline in the treated arm compared to sham-treated control arm at the 12 month time point. Sham-treated participants may be offered cross-over to active treatment after 12 months, and all participants will continue to receive treatment for a total of 24 months after which they may be offered participation in an open label extension trial. Treatment of the second eye will be adaptively incorporated into the trial.

07:12 EDT Regeneron sees 2019 Sanofi collaboration revenue $510M-$560M - Sees 2019: Effective tax rate 14%-16%; CapEx $410M-$490M.

07:10 EDT ADMA Biologics submits response to FDA for Bivigam CRL - ADMA Biologics announces that the company has submitted responses to the U.S. FDAComplete Response Letter received on December 19, 2018 for BIVIGAM's Prior Approval Supplement. The cmpany anticipates receiving an acknowledgement letter from the FDA within 30 days, and plans to provide appropriate updates on the progress of the BIVIGAM PAS review.

07:09 EDT Kala Pharmaceuticals announces launch of INVELTYS - Kala Pharmaceuticals announced the launch of INVELTYS 1%, the first and only twice-daily ocular corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery, and the hiring of the specialty ophthalmology sales organization. INVELTYS is now in national and regional United States pharmaceutical distribution centers, and patients have access to INVELTYS through their local retail pharmacies. A highly experienced ophthalmology specialty sales force of 57 territory sales managers has been hired, trained and deployed. The territory sales managers have on average more than eight years of ophthalmic sales experience and more than 13 years of pharmaceutical sales experience. An experienced sales leadership team has also been hired, with on average over nine years of ophthalmic sales experience and nearly eight years of pharmaceutical sales leadership experience. In addition, the payor account team, which averages over 16 years of account director experience, is actively engaged in contract discussions with Commercial and Medicare Part D health plans. INVELTYS was approved in August 2018 as the first and only twice-daily ocular corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. INVELTYS utilizes Kala's proprietary AMPPLIFY Drug Delivery Technology to enhance penetration into target tissues of the eye. In preclinical studies, the AMPPLIFY technology increased delivery of loteprednol etabonate into ocular tissues more than three-fold compared to current LE products by facilitating penetration through the tear film mucins.

07:08 EDT Intercept sees read-out of data from Phase 3 Regenerate trial analysis in Q1 - Intercept Pharmaceuticals announced two updates to its NASH development program. Intercept anticipates that it will read-out top-line data from the interim analysis of its Phase 3 REGENERATE trial evaluating obeticholic acid in non-cirrhotic NASH patients with advanced liver fibrosis in the first quarter of 2019. Intercept also expects to complete enrollment of its Phase 3 REVERSE trial evaluating OCA in NASH patients with compensated cirrhosis in 2019. "2019 is expected to be a transformative year for Intercept, as we look forward to announcing top-line results from the REGENERATE interim analysis this quarter and continuing to advance our leading Phase 3 development program for the treatment of NASH patients with advanced liver fibrosis and compensated cirrhosis where we believe there is the greatest unmet medical need," said Mark Pruzanski, M.D., Intercept's President and CEO.

07:06 EDT Covanta begins construction of Total Ash Processing System - Covanta announced that it has commenced construction of its first Total Ash Processing System, with operational start-up expected in the second half of 2019. Located in Fairless Hills, Pennsylvania, adjacent to Covanta's existing metals processing facility, the first TAPS plant is designed to process over 400,000 tons of ash from multiple Covanta Energy-from-Waste facilities, recovering previously untapped value from these waste streams.

07:05 EDT Amicus sees FY19 Galafold revenue $160M-$180M - The company expects to end 2019 with approximately $300M in cash on hand. The current cash position is anticipated to fund ongoing operations into at least mid- 2021.

07:04 EDT Insulet appoints Wayde McMillan as CFO - Insulet announced that Wayde McMillan has been appointed Executive Vice President and CFO, effective March 1, 2019, succeeding Michael Levitz. To ensure a smooth and successful transition, McMillan will join the company in February and Levitz will continue with the Company in an advisory capacity for a period following the succession effective date.

06:58 EDT Nucor to spend $1.35B to build plate mill in U.S. midwest - Nucor announced plans to build a state-of-the-art plate mill in the U.S. Midwest. Nucor's board has approved an investment of $1.35B to build the mill, which is expected to be fully operational in 2022 and will be capable of producing 1.2M tons per year of steel plate products. The project is expected to create approximately 400 full-time jobs.

06:49 EDT Commercial Metals says Q2 will include normal seasonality - "We remain optimistic about the demand outlook in our key markets. Our second quarter of fiscal 2019 will include normal seasonality, which will reduce shipment rates at our facilities; however we expect the quarter to be strong in comparison to historical second quarter results, due to the contribution from our strategic growth initiatives," said CEO Barbara Smith. "We expect to see continued growth from our investment in the new Durant, OK micro mill, as well as growth from the ongoing integration of the newly acquired rebar assets. We are confident that these will position us well to serve our customers in this period of strong demand and deliver enhanced returns to our shareholders."

06:49 EDT Quarterhill subsidiary provides update on patent litigation with Apple - Wi-LAN, a Quarterhill (QTRH) company provided an update on ongoing litigation. In a trial verdict rendered on August 1, 2018 in the United States District Court for the Southern District of California a jury awarded WiLAN $145.1M in damages against Apple (AAPL). for infringement of WiLAN's U.S. Patents. In a January 4 ruling, Judge Dana Sabraw upheld the jury verdict that Apple infringed the two WiLAN patents. The court did not lower the damages award but did grant WiLAN the option to accept either reduced damages in the amount of $10M or a new trial limited to determining the amount of damages only. This ruling confirms infringement and the only issue between the parties remains damages. The judge also mandated more non-binding settlement discussions between the parties. WiLAN will remain open to a fair and reasonable settlement with Apple while remaining confident of the merits of its damages claims and will continue to assess its various options in the next stages of the litigation process.

06:46 EDT Pentair to acquire Aquion for $160M in cash - Pentair announced that it has entered into a definitive agreement to acquire Aquion for $160M in cash, subject to customary adjustments. Aquion offers a diverse line of water conditioners, water filters, drinking-water purifiers, ozone and ultraviolet disinfection systems, reverse osmosis systems and acid neutralizers for the residential and commercial water treatment industry. The transaction is anticipated to be completed in the first quarter of 2019, subject to customary closing conditions and necessary regulatory approvals. Pentair plans to release its fourth quarter and full year 2018 results on January 29, at which time it anticipates providing its 2019 outlook, including the projected financial impact of this transaction.

06:41 EDT Suncor reports Q4 total upstream production 831,000 boe/d - Suncor provided an operations update for the fourth quarter of 2018, highlighting total upstream production of 831,000 barrels of oil equivalent per day, which is a quarterly production record and represents an increase of 12% from the third quarter of 2018. This record-breaking quarter reflects the results of the significant investment developing Fort Hills, and Suncor's ongoing operational excellence focus across its assets, particularly at the Syncrude joint venture. Oil sands operations produced approximately 433,000 barrels per day in the quarter. Fort Hills produced 183,000 bbls/d for the quarter, approximately 100,000 bbls/d net to Suncor, representing 94% of nameplate capacity. Syncrude production was 355,000 bbls/d for the quarter, 209,000 bbls/d net to Suncor, representing 101% of nameplate capacity, and reflecting a new quarterly production record. Total production from Exploration & Production was 90,000 boe/d during the fourth quarter. Refining and Marketing operations demonstrated solid reliability with average refinery utilization of 101% for record quarterly crude throughput of 468,000 bbls/d. Refined product demand remained strong during the quarter.

06:34 EDT Immersion names Ramzi Haidamus as CEO, succeeding Tom Lacey - Immersion (IMMR) announced that Ramzi Haidamus will become the company's CEO and a member of the Immersion Board of Directors, effective January 21. Haidamus succeeds Tom Lacey, the company's Interim CEO, who will remain a Board member of Immersion. Haidamus was president of Nokia Technologies (NOK) from 2014 to 2016.

06:31 EDT Eli Lilly agrees to acquire Loxo Oncology for $235 per share or about $8B

06:15 EDT Vital Therapies to acquire all outstanding shares of Immunic in all-stock deal - Vital Therapies and Immunic AG, a private clinical-stage biotechnology company in Planegg-Martinsried, Germany, announced that they have entered into a definitive agreement under which Vital Therapies is expected to acquire all of the outstanding shares in Immunic in exchange for newly issued shares of Vital Therapies in an all-stock transaction. The company will focus on advancing Immunic's pipeline of treatments for chronic inflammatory and autoimmune diseases. Upon closing of the transaction, the company is expected to operate under the name Immunicand trade on the Nasdaq Global Market. An investor syndicate including Life Sciences Partners, Omega Funds, Fund+, LifeCare Partners, Bayern Kapital, High-Tech Grunderfonds and IBG Beteiligungsgesellschaft Sachsen-Anhalt has committed to invest approximately EUR26M in the company at the closing of the transaction. This financing will help fund the further development of Immunic's pharmaceutical product candidates and is expected to be consummated before or concurrently with the closing of the transaction, which is contingent upon this financing. The total cash balance of the company following the closing of the transaction and concurrent financing is expected to be between $35M-$40M and would be sufficient to fund development into Q3 of 2020. Immunic's lead program, IMU-838, is an orally available selective immune modulator which inhibits the intracellular metabolism of activated immune cells by blocking the enzyme dihydroorotate dehydrogenase. IMU-838 was successfully tested in two phase 1 clinical trials in 2017 and is currently being tested in a phase 2 trial in patients with ulcerative colitis. Immunic intends to initiate additional phase 2 trials in patients with Crohn's disease and multiple sclerosis throughout the course of 2019. Furthermore, the Mayo Clinic plans to start a phase 2 study testing IMU-838 activity in patients with primary sclerosing cholangitis in Q1. Immunic's second asset is IMU-935, an orally available small molecule inverse agonist of RORyt, a nuclear receptor known to influence the production of cytokines involved in autoimmune disease. The IMU-935 program, currently in preclinical development, is expected to enter clinical phase 1 trials in mid-2019. In November 2018, Immunic entered into an exclusive global option and license agreement with Tokyo-based Daiichi Sankyo for IMU-856, a novel, orally available small molecule currently in preclinical development. IMU-856 targets the restoration of the intestinal barrier function, whose disruption is known to be prominently involved in the initiation of inflammatory bowel diseases like ulcerative colitis and Crohn's disease, and also in disease relapse. Restoration of the intestinal barrier function may provide an important new therapeutic option by lessening or avoiding the immuno-suppression associated with current therapies. Immunic currently expects IMU-856 to enter clinical trials in the first half of 2020. Under the terms of the agreement, on a pro forma basis and after giving effect to the concurrent financing, current Vital Therapies stockholders are expected to own approximately 11% of the company and current Immunic stockholders are expected to own approximately 89% of the company. The actual allocation will be subject to adjustment based on Vital Therapies' net cash balance at the closing of the transaction. Prior to closing, Vital Therapies will seek stockholder approval to effect a reverse split of its outstanding common stock to satisfy listing requirements of the Nasdaq Global Market. With the signing of the exchange agreement between the two parties, Russell Cox, Vital Therapies' CEO, will be leaving the company in the near term. Upon Cox's departure, Duane Nash, Vital Therapies' current president, will serve as interim CEO. The transaction has been approved by the board of directors of both companies and the stockholders of Immunic. The transaction is expected to close in Q2, subject to the approval of Vital Therapies stockholders at a special meeting of stockholders, as well as other customary conditions.

06:11 EDT Wright Medical announces organizational changes - Kevin Cordell, Wright's current president, U.S., is being promoted to the newly created position of executive vice president, chief global commercial officer. Cordell joined Wright in 2014 and has more than 25 years of experience as a global medical technologies commercial leader with extensive experience leading direct sales forces. Lance Berry, Wright's current senior vice president and CFO, is being promoted to the newly created position of executive vice president, CFO and operations officer. Berry is a long-tenured, proven Wright executive with more than 15 years of industry experience, including extensive knowledge of the company's operations, systems and processes.

06:09 EDT Wright Medical announces three-year financial targets for 2019-2021 - As previously announced, the company anticipates achieving its goal of 20% adjusted EBITDA margins for the full fourth quarter of 2019. The company also announced new three-year financial targets for 2019 through 2021: Deliver double-digit, constant currency net sales growth each year; Maintain adjusted gross margin in the high 70s% range each year; Expand adjusted EBITDA margin to the mid-20% range exiting 2021.

06:06 EDT Axsome Therapeutics: AXS-05 achieves primary endpoint in Phase 2 trial - Axsome Therapeutics announced that AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity, met the prespecified primary endpoint and significantly improved symptoms of depression in the ASCEND Phase 2 trial in major depressive disorder. The ASCEND study is a randomized, double-blind, active-controlled, multi-center, U.S. trial, in which 80 adult patients with confirmed moderate to severe MDD were treated either with AXS-05, or the active comparator bupropion, twice daily for 6 weeks. AXS-05 met the prespecified primary endpoint by demonstrating a highly statistically significant reduction in the Montgomery-Asberg Depression Rating Scale total score, averaged over the 6-week treatment period (overall treatment effect), as compared to bupropion. At Week 6, AXS-05 demonstrated a 17.2 point reduction in the MADRS total score compared to a 12.1 point reduction for bupropion. AXS-05 rapidly reduced depressive symptoms, demonstrating a statistically significant improvement over bupropion on the Clinical Global Impression-Improvement scale at Week 1. Starting at Week 1, AXS-05 achieved numerical superiority over bupropion on the MADRS total score, with statistical significance achieved at Week 2 and maintained at all time points thereafter. At Week 6, 47% of patients who received AXS-05 achieved remission, prospectively defined as a score of 10 or less on the MADRS, compared with 16% of patients who received bupropion. AXS-05 was superior to bupropion on multiple prespecified secondary endpoints, with statistically significant effects demonstrated on most, including the following: MADRS-6; percentage of responders on MADRS-6; CGI-I; Clinical Global Impression-Severity scale; percentage of patients achieving remission on MADRS. Additionally, the treatment effect observed with bupropion in the study was consistent with that observed in prior published trials.

06:03 EDT Sage Therapeutics: SAGE-217 meets primary, secondary endpoints in Phase 3 trial - Sage Therapeutics reported top-line results from the Phase 3 ROBIN study. This study evaluated the effect of SAGE-217 30 mg on depressive symptoms in women with postpartum depression . After two weeks of outpatient treatment, patients treated with SAGE-217 had a statistically significant improvement of 17.8 points in the Hamilton Rating Scale for Depression score, compared to 13.6 for placebo, with statistically significant reductions in HAMD-17 compared to placebo maintained through the end of the four-week follow-up. Remission was achieved in 45% of patients treated with SAGE-217 for two weeks as measured by the HAMD-17 compared with 23% of patients receiving placebo. Results from secondary endpoints were statistically significant and consistent with the primary endpoint. SAGE-217 was generally well-tolerated with a safety profile consistent with that seen in earlier SAGE-217 trials. Overall reports of AEs were similar between SAGE-217 (58%) and placebo (51%). Two subjects experienced serious adverse events, one subject in each group.

06:02 EDT Samsung smart TVs to launch iTunes movies and TV shows in Spring 2019 - Samsung Electronics (SSNLF) announced on Sunday that it will offer iTunes Movies and TV Shows and Apple (AAPL) AirPlay 2 support on 2019 Samsung Smart TV models beginning this spring. Support on 2018 Samsung Smart TVs will be made available via firmware update. Additionally, a new iTunes Movies and TV Shows app will debut only on Samsung Smart TVs in more than 100 countries. AirPlay 2 support will be available on Samsung Smart TVs in 190 countries worldwide. With the new iTunes Movies and TV Shows app on Samsung Smart TVs, Samsung customers can access their existing iTunes library and browse the iTunes Store to buy or rent from a selection of hundreds of thousands of movies and TV episodes.

06:01 EDT Radware to acquire ShieldSquare, terms not disclosed - Radware announced that it has entered into a definitive agreement to acquire ShieldSquare, a market-leading bot management solutions provider. The transaction is expected to close during the first quarter of 2019, subject to customary closing and regulatory conditions.

05:53 EDT Ambarella enters partnership with Smart Eye - Ambarella announced they are partnering to deliver a Driver Monitoring System, or DMS, platform that tracks driver actions and intentions. The platform is based on Ambarella's CV22AQ CVflow computer vision processor, which offers best-in-class image processing and high-performance AI computing at low power consumption, typically below 2.5 watts. Smart Eye AI software running on CV22AQ will make it possible for automotive OEMs and tier-1s to deploy a new generation of driver and in-cabin monitoring systems with advanced AI features, increasing safety and convenience for drivers and passengers.

05:42 EDT Exxon Mobil begins drilling Haimara-1 exploration well offshore Guyana - ExxonMobil said today that it has begun drilling the Haimara-1 exploration well offshore Guyana, the first of two planned wells in January. The Stena Carron drillship is drilling the well, which is located 19 miles east of the Pluma-1 discovery in the southeast Stabroek Block. The Noble Tom Madden drillship is expected to drill the second well, Tilapia-1, about three miles west of the Longtail-1 discovery. The Tilapia-1 well is located in the growing Turbot area.

05:15 EDT Biohaven announces acceptance of rimegepant IND filing in China - Biohaven Pharmaceutical and its wholly-owned Asia-Pacific subsidiary company, BioShin, announced the National Medical Products Administration, or NMPA, formerly, the China FDA, has accepted the investigational new drug, or IND, application for rimegepant, Biohaven's lead oral calcitonin gene-related peptide, or CGRP, receptor antagonist product candidate, for the treatment of migraine. CGRP receptor antagonists represent a novel class of drug candidates for the treatment of migraine and are the first new class for the treatment of migraine in over 25 years. CGRP receptor antagonists potentially offer an alternative to current agents, particularly for patients who have contraindications to the use of triptans, such as those with underlying cardiovascular diseases, or those who have an inadequate response to standard therapies.